Recurrent Endometrial Carcinoma
Conditions
Brief summary
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.
Detailed description
PRIMARY OBJECTIVES: I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer, in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Interventions
BIOLOGICALziv-aflibercept
Sponsors
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed endometrial carcinoma, meeting both of the following criteria: * Recurrent or persistent disease * Refractory to curative therapy or established treatments * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy * Must have received one prior chemotherapeutic regimen for management of endometrial carcinoma (initial treatment may include high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment) * Not a candidate for a higher priority GOG protocol * No history or evidence of primary brain tumor or brain metastases * GOG performance status (PS) 0-2 (patients who received 1 prior regimen) OR GOG PS 0-1 (patients who received 2 prior regimens) * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Urine protein:creatinine ratio \< 1.0 OR urine protein \< 1.0 g by 24-hour urine collection * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * PT/PTT/INR ≤ 1.5 times ULN * In-range INR (between 2 and 3) allowed if patient is on a stable dose of therapeutic warfarin * QTc \< 500 msec * No evidence of serious ventricular arrhythmia * Ventricular tachycardia or ventricular fibrillation must be \< 3 beats in a row * LVEF normal * Ejection fraction ≥ 50% (for patients who received prior anthracycline, including doxorubicin hydrochloride and/or doxorubicin hydrochloride liposome) * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension, defined as systolic blood pressure (BP) \> 140 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina within the past 6 months * NYHA class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ grade 2 * Cerebrovascular accident (i.e., CVA or stroke), transient ischemic attack, or subarachnoid hemorrhage within the past 6 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy * No HIV positivity * No neuropathy (sensory and motor) \> grade 1 * No active infection requiring antibiotics * No other invasive malignancies or any evidence of other cancer within the past 5 years except for nonmelanoma skin cancer * No serious nonhealing wound, ulcer, or bone fracture * No history of abdominal fistula or gastrointestinal perforation * No history or evidence of seizures not controlled with standard medical therapy * No intra-abdominal abscess within the past 28 days * No active bleeding or pathologic conditions that carry a high risk of bleeding (e.g., bleeding disorder, coagulopathy, or tumor involving major vessels) * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * No significant traumatic injury within the past 28 days * No concurrent combination antiretroviral therapy for HIV-positive patients * Recovered from prior surgery * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered * At least 1 week since prior hormonal therapy * Concurrent hormone replacement therapy allowed * At least 3 weeks since any other prior therapy, including immunologic agents * One additional prior cytotoxic regimen for management of recurrent or persistent endometrial cancer allowed * Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa * More than 28 days since prior major surgery or open biopsy * More than 7 days since prior minor surgery, fine needle aspirates, or core biopsies * No prior cancer treatment that would preclude study compliance * No prior noncytotoxic chemotherapy for management of recurrent or persistent endometrial disease * No prior VEGF Trap or other VEGF pathway-targeted therapy * More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer * More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin * Patient must remain free of recurrent or metastatic disease * More than 5 years since prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer * More than 3 years since prior adjuvant chemotherapy for localized breast cancer * Patient must remain free of recurrent or metastatic disease * Concurrent low-molecular weight heparin allowed for the prevention or treatment of venous thromboembolic disease if condition is considered clinically stable with treatment * No other concurrent investigational agents * No concurrent major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Month Progression-free Survival | At 6 monthsEvery other cycle during treatment for the first 6 months. | Number of participants who survived progression-free for more than 6 months. |
| Objective Tumor Response (RECIST 1.0) | Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years. | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment | Adverse events at least possibly related to the study agent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Progression-free Survival | Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years. | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| Duration of Overall Survival | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years. | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
Countries
United States
Participant flow
Recruitment details
Patients were accrued to the first stage of accrual from 11/5/2007 to 6/2/2008. Patients were accrued to the second stage between 4/6/2009 and 7/13/2009. They received 4 mg/kg IV of VEGF-Trap every two weeks. One cycle was 28 days.
Pre-assignment details
Patients were required to have had one prior chemotherapeutic regimen for the treatment of endometrial carcinoma. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Aflibercept) Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible - second primary | 1 |
| Overall Study | Ineligible - wrong cell type | 1 |
| Overall Study | Ineligible - wrong primary | 2 |
| Overall Study | Never treated | 1 |
Baseline characteristics
| Characteristic | Treatment (Aflibercept) |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 8.4 |
| Age, Customized 40-49 years | 3 participants |
| Age, Customized 50-59 years | 13 participants |
| Age, Customized 60-69 years | 15 participants |
| Age, Customized 70-79 years | 12 participants |
| Age, Customized 80-89 years | 1 participants |
| Cell Type Adenocarcinoma, Unspecified | 1 participants |
| Cell Type Carcinsarcoma, MMT | 1 participants |
| Cell Type Clear Cell Carcinoma | 1 participants |
| Cell Type Endometrioid Adenocarcinoma | 23 participants |
| Cell Type Mixed Epithelial Carcinoma | 6 participants |
| Cell Type Mucinous Adenocarcinoma | 1 participants |
| Cell Type Serous Adenocarcinoma | 11 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease | 44 participants |
| Reason Off Study Therapy Death | 3 participants |
| Reason Off Study Therapy Disease Progression | 25 participants |
| Reason Off Study Therapy Other | 1 participants |
| Reason Off Study Therapy Refused Further Treatment | 1 participants |
| Reason Off Study Therapy Toxicity as permitted | 14 participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Response Increase Disease | 16 participants |
| Tumor Response Indeterminate | 11 participants |
| Tumor Response Partial Response | 3 participants |
| Tumor Response Stable Disease | 14 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 44 |
| serious Total, serious adverse events | 24 / 44 |
Outcome results
Primary
6 Month Progression-free Survival
Number of participants who survived progression-free for more than 6 months.
Time frame: At 6 monthsEvery other cycle during treatment for the first 6 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Aflibercept) | 6 Month Progression-free Survival | 18 participants |
Primary
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Adverse events at least possibly related to the study agent.
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Population: Eligible and evaluable patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 27 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 42 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 25 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 36 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 13 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 40 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 36 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 39 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 40 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 23 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 38 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 16 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 36 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 41 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 40 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 41 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 42 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 41 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 25 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 14 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 23 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 37 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 43 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 31 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 32 Participants |
| Treatment (Aflibercept) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 39 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 12 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 13 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 13 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 15 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 9 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 15 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 6 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 9 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 12 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 10 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 4 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 10 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 8 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 3 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/renal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/visual | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 0 Participants |
Primary
Objective Tumor Response (RECIST 1.0)
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.
Population: Eligible and evaluable patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Aflibercept) | Objective Tumor Response (RECIST 1.0) | Complete Response | 0 participants |
| Treatment (Aflibercept) | Objective Tumor Response (RECIST 1.0) | Partial Response | 3 participants |
Secondary
Duration of Overall Survival
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Population: Eligible and evaluable patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Aflibercept) | Duration of Overall Survival | 14.5 months |
Secondary
Duration of Progression-free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.
Population: Eligible and evaluable patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Aflibercept) | Duration of Progression-free Survival | 2.9 months |