Cervical Squamous Cell Carcinoma, Recurrent Cervical Cancer
Conditions
Brief summary
This phase II trial is to see if bevacizumab works in treating patients who have persistent or recurrent cancer of the cervix. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them.
Detailed description
OBJECTIVES: I. Determine the cytostatic antitumor activity of bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with persistent or recurrent squamous cell carcinoma of the cervix. II. Determine the nature and degree of toxicity of this drug in these patients. III. Estimate the distribution of PFS and overall survival for patients treated with this drug. IV. Determine the frequency of clinical response (partial and complete) in patients treated with this drug. V. Determine the role of age and initial performance status as prognostic factors in patients treated with this drug. VI. Determine whether biological and imaging markers are associated with clinical efficacy of this drug, such as 6-month PFS, in these patients. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-38 months.
Interventions
BIOLOGICALbevacizumab
Given IV
OTHERlaboratory biomarker analysis
Correlative studies
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 persistent or recurrent squamous cell carcinoma (SCC) of the cervix * Patients must have received at least 1, but no more than 2, prior cytotoxic chemotherapy regimens for advanced, metastatic, or recurrent SCC of the cervix * Chemotherapy administered as a radio-sensitizer does not count as 1 regimen * Documented disease progression * At least 1 unidimensionally measurable lesion\* * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No tumor involving major blood vessels * No history or physical evidence of CNS disease, including primary or metastatic brain tumor * Ineligible for a higher priority Gynecological Oncology Group (GOG) protocol (if one exists), including any active GOG phase III protocol for the same patient population * Performance status - GOG 0-2 (if received 1 prior regimen) * Performance status - GOG 0-1 (if received 2 prior regimens) * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No known bleeding disorder or coagulopathy * No other active bleeding or pathologic condition that would confer a high risk of bleeding * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * INR ≤ 1.5 (or 2-3 for patients on a stable dose of therapeutic warfarin or low molecular weight heparin) * PTT \< 1.2 times control * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 60 mL/min * No proteinuria * Urine protein \< 1+ on dipstick or \< 30 mg/dL * Urine protein \< 1000 mg by 24-hour urine collection * No clinically significant cardiovascular disease * No uncontrolled hypertension * No myocardial infarction or unstable angina within the past 6 months * No New York Heart Association grade II-IV congestive heart failure * No serious cardiac arrhythmia requiring medication * No grade II or greater peripheral vascular disease * No history of stroke within the past 5 years * No greater than grade 1 sensory or motor neuropathy * No active infection requiring parenteral antibiotics * No serious nonhealing wound, ulcer, or bone fracture * No history or physical evidence of seizures not controlled with standard medical therapy * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer * No significant traumatic injury within the past 4 weeks * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment * No prior bevacizumab * At least 3 weeks since prior immunologic agents for SCC of the cervix * See Disease Characteristics * Recovered from prior chemotherapy * No prior non-cytotoxic chemotherapy for persistent or recurrent disease * At least 1 week since prior hormonal therapy for SCC of the cervix * Concurrent hormone replacement therapy allowed * See Disease Characteristics * Recovered from prior radiotherapy * Recovered from recent prior surgery * At least 4 weeks since prior major surgical procedure or open biopsy * At least 1 week since prior placement of vascular access device or core biopsy * No concurrent major surgical procedure * At least 3 weeks since other prior therapy for SCC of the cervix * No prior anticancer therapy that would preclude study therapy * No concurrent anticoagulants other than those required to maintain the patency of indwelling IV catheters * No concurrent chronic daily aspirin greater than 325 mg/day or other nonsteroidal anti-inflammatory medications that are known to inhibit platelet function at doses used for chronic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Greater Than 6 Months | Every other 3-week treatment cycle for 6 months | Whether or not the patient survived progression-free for at least 6 months. |
| Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Every cycle and 30 days after the end of treatment. (average 5 months) | The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Progression-free Survival | Every other 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 | 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. |
| Tumor Response | Every other cycle during treatment and at the time of treatment discontinuation. (average 5 months) | 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. |
| Age at Enrollment | Baseline | — |
| Performance Status | Baseline | Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours. |
| Overall Survival | From study entry to death or last contact, up to 5 years. | The observed length of life from entry into the study to death or the date of last contact. |
Countries
United States
Participant flow
Recruitment details
The study was activated on 4/29/2002 and closed to accrual on 11/6/2006 (suspended from 2/7/2005 to 10/30/2005).
Pre-assignment details
Patients must have persistent or recurrent squamous cell carcinoma of the cervix with documented disease progression. Patients were required to have measurable disease at time of study entry. They were required to have had a prior cytotoxic regimen.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible: improper prior treatment | 1 |
| Overall Study | Ineligible: wrong cell type | 1 |
| Overall Study | Ineligible: wrong primary | 1 |
| Overall Study | Never treated | 1 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Continuous | 46.4 years STANDARD_DEVIATION 9.3 |
| Age, Customized 20-29 years | 1 participants |
| Age, Customized 30-39 years | 11 participants |
| Age, Customized 40-49 years | 17 participants |
| Age, Customized 50-59 years | 12 participants |
| Age, Customized 60-69 years | 5 participants |
| Histologic Type Adenosquamous | 3 participants |
| Histologic Type Squamous Cell Carcinoma | 43 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent | 45 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Stage Unspecified | 1 participants |
| Region of Enrollment Canada | 1 participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 46 |
| serious Total, serious adverse events | 27 / 46 |
Outcome results
Primary
Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0
The maximum severity of each adverse event per patient, graded according to Common Toxicity Criteria version 2.0, is reported. Events were restricted to those reported as at least possibly related to study drug.
Time frame: Every cycle and 30 days after the end of treatment. (average 5 months)
Population: Eligible and treated patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 41 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 40 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 41 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 42 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 22 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 34 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 35 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 43 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 45 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 41 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 39 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 38 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 27 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 34 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 33 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 26 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 43 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 36 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 25 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 38 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 41 Participants |
| Bevacizumab | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 29 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 11 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 16 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 8 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 3 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 2 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 2 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 2 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 1 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 3 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 16 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 8 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 0 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 1 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 8 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 3 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 5 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 1 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 6 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 4 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 7 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 5 Participants |
| Grade 1 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 3 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 1 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 10 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 2 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 2 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 6 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 5 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 10 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 3 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 2 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 3 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 0 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 2 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 3 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 5 Participants |
| Grade 2 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 5 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 3 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 4 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 1 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 1 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 1 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 1 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 6 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 2 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 0 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 4 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 7 Participants |
| Grade 3 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 1 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 1 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 1 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 1 Participants |
| Grade 4 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pulmonary | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombosis Embolism | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neuropathy sensory | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other hematologic | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Genitourinary/renal | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Allergy | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other cardiovascular | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Gastrointestinal | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Other neurologic | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Infection | 1 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Anemia | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hepatic | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Hypertension | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Metabolic | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Coagulation | 0 Participants |
| Grade 5 (CTCAE v 2.0) | Maximum Severity of Each Adverse Event Per Patient, Graded According to Common Toxicity Criteria Version 2.0 | Pain | 0 Participants |
Primary
Progression-free Survival Greater Than 6 Months
Whether or not the patient survived progression-free for at least 6 months.
Time frame: Every other 3-week treatment cycle for 6 months
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Progression-free Survival Greater Than 6 Months | 23.9 percentage of participants |
Secondary
Age at Enrollment
Time frame: Baseline
Population: Eligible and treated patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bevacizumab | Age at Enrollment | 20-29 years | 1 Participants |
| Bevacizumab | Age at Enrollment | 30-39 years | 11 Participants |
| Bevacizumab | Age at Enrollment | 40-49 years | 17 Participants |
| Bevacizumab | Age at Enrollment | 50-59 years | 12 Participants |
| Bevacizumab | Age at Enrollment | 60-69 years | 5 Participants |
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, 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 treated patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Duration of Progression-free Survival | 3.40 months |
Secondary
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years.
Population: Eligible and treated patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Overall Survival | 7.3 months |
Secondary
Performance Status
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time frame: Baseline
Population: Eligible and treated patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bevacizumab | Performance Status | Performance Status 0 | 22 Participants |
| Bevacizumab | Performance Status | Performance Status 1 | 23 Participants |
| Bevacizumab | Performance Status | Performance Status 2 | 1 Participants |
Secondary
Tumor Response
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 and at the time of treatment discontinuation. (average 5 months)
Population: Eligible and treated patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Tumor Response | 10.9 percentage of participants |