Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
Conditions
Brief summary
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus. II. Determine the toxicity of this drug in these patients. Secondary I. Determine the duration of PFS and overall survival of these patients. OUTLINE: This is a nonrandomized, multicenter study. Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat 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. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Interventions
DRUGtemsirolimus
Given IV
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 ovarian epithelial, fallopian tube or primary peritoneal cavity cancer * Recurrent or refractory * Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required * Initial treatment may have included any of the following: * High-dose therapy * Intraperitoneal therapy * Consolidation therapy * Noncytotoxic agents * Extended therapy administered after surgical or nonsurgical assessment * Patients must meet ≥ 1 of the following criteria: * Treatment-free interval after platinum therapy of \< 12 months for patients who received only 1 platinum-based regimen * Progressed during platinum-based therapy * Refractory disease after a platinum-based regimen * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have ≥ 1 target lesion * Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy * Not eligible for a higher priority GOG protocol, if one exists * GOG performance status (PS) 0-2 for patients who have receive one prior regimen OR GOG PS 0-1 for patients who have received 2-3 prior regimens * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * No neuropathy (sensory and motor) \> grade 2 * Fasting cholesterol \< 350 mg/dL * Fasting triglycerides \< 400 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics (with the exception of uncomplicated UTI) * No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer * See Disease Characteristics * Recovered from prior surgery, radiotherapy, or chemotherapy * At least 1 week since prior hormonal therapy directed at the malignant tumor * At least 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 * At least 3 years since prior adjuvant chemotherapy for localized breast cancer * Patient must remain free of recurrent or metastatic disease * At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents * No prior temsirolimus * No prior cancer treatment that would preclude study therapy * No prior radiotherapy to \> 25% of marrow-bearing areas * No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer * No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen * Two additional cytotoxic regimens (defined as 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) for management of recurrent or persistent ovarian disease allowed * Concurrent low molecular weight heparin allowed provided PT/INR ≤ 1.5 * Concurrent hormone replacement therapy allowed * No concurrent amifostine or other protective reagents * No concurrent prophylactic filgrastim (G-CSF)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Up to 5 years | Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions. |
| 6 Month Progression-free Survival (PFS) | 6 months | Number of participants who survived progression-free for more than 6 months. |
| Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Up to 5 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of Progression-free Survival | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reason Off Study Therapy | from study entry until end of study treatment | — |
| Patient Vital Status | Study entry up to 2 years | Patients alive or dead after 24 months from time of study entry |
Countries
United States
Participant flow
Recruitment details
Patients were accrued to the first stage of accrual from 2/5/07 to 9/4/07. Patients were accrued to the second stage of accrual between 5/7/08 to 8/25/08. They received 25 mg IV of CCI-779 weekly. One cycle was 28 days.
Pre-assignment details
Patients were required to have had one regimen of a platinum agent for the treatment of ovarian cancer. 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 (Temsirolimus) Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Improper pre-protocol treatment | 3 |
| Overall Study | Never treated | 1 |
| Overall Study | Non-measurable | 1 |
| Overall Study | Required test not done | 1 |
Baseline characteristics
| Characteristic | Treatment (Temsirolimus) |
|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 13 |
| Age, Customized 20-29 years | 2 participants |
| Age, Customized 40-49 years | 7 participants |
| Age, Customized 50-59 years | 15 participants |
| Age, Customized 60-69 years | 11 participants |
| Age, Customized 70-79 years | 16 participants |
| Age, Customized 80-89 years | 3 participants |
| Cell Type Adenocarcinoma, unspecified | 8 participants |
| Cell Type Clear Cell Carcinoma | 3 participants |
| Cell Type Endometrioid Adenocarcinoma | 4 participants |
| Cell Type Serous Adenocarcinoma | 39 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease | 54 participants |
| Region of Enrollment United States | 54 participants |
| Sex: Female, Male Female | 54 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 | 44 / 54 |
| serious Total, serious adverse events | 5 / 54 |
Outcome results
Primary
6 Month Progression-free Survival (PFS)
Number of participants who survived progression-free for more than 6 months.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Temsirolimus) | 6 Month Progression-free Survival (PFS) | 13 participants |
Primary
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Time frame: Up to 5 years
Population: Eligible and evaluable patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Thrombocytopenia | 18 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Nausea | 19 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Dermatologic | 24 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Constitutional | 23 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Auditory/Ear | 1 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Coagulation | 2 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Cardiac | 3 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Leukopenia | 14 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pain | 13 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Ocular/Visual | 1 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other Neurological | 5 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neutropenia | 6 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vascular | 0 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neurosensory | 6 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Musculoskeletal | 2 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Metabolic | 17 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Anemia | 20 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Sexual/Reproductive | 1 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Lymphatics | 3 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Infection | 0 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Hemorrhage | 5 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other hematologic | 0 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pulmonary | 17 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Genitourinary/Renal | 4 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Gastrointestinal | 16 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vomiting | 2 Participants |
| Treatment (Temsirolimus) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Allergy/Immunology | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Auditory/Ear | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Leukopenia | 14 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Thrombocytopenia | 5 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neutropenia | 12 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Anemia | 19 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other hematologic | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Allergy/Immunology | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Cardiac | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Coagulation | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Constitutional | 15 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Dermatologic | 10 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Nausea | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vomiting | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Gastrointestinal | 19 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Genitourinary/Renal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Hemorrhage | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Infection | 5 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Lymphatics | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Metabolic | 12 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Musculoskeletal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neurosensory | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other Neurological | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Ocular/Visual | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pain | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pulmonary | 5 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Sexual/Reproductive | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vascular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Coagulation | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vomiting | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Infection | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Dermatologic | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neurosensory | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Anemia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Lymphatics | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Nausea | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neutropenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Musculoskeletal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Cardiac | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Metabolic | 8 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Gastrointestinal | 6 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Sexual/Reproductive | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Allergy/Immunology | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Auditory/Ear | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other hematologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vascular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Genitourinary/Renal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pain | 6 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Ocular/Visual | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Leukopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pulmonary | 4 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Hemorrhage | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Constitutional | 4 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other Neurological | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neurosensory | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pain | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Nausea | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vomiting | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Gastrointestinal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Genitourinary/Renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Anemia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Infection | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Leukopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vascular | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Metabolic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neutropenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Sexual/Reproductive | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other Neurological | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Ocular/Visual | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Auditory/Ear | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Cardiac | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Constitutional | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Allergy/Immunology | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Allergy/Immunology | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other Neurological | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vascular | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Anemia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Genitourinary/Renal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Other hematologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Nausea | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Auditory/Ear | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Gastrointestinal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Ocular/Visual | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Cardiac | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pulmonary | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Vomiting | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Metabolic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Pain | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Musculoskeletal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Lymphatics | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Infection | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Coagulation | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Neurosensory | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) | Sexual/Reproductive | 0 Participants |
Primary
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.
Time frame: Up to 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Temsirolimus) | Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Partial Response | 5 participants |
| Treatment (Temsirolimus) | Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Stable Disease | 22 participants |
| Treatment (Temsirolimus) | Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Increase Disease | 21 participants |
| Treatment (Temsirolimus) | Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Indeterminate | 6 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 (Temsirolimus) | Duration of Overall Survival | 11.60 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: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years
Population: Eligible and evaluable patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Temsirolimus) | Duration of Progression-free Survival | 3.19 months |
Other Pre-specified
Patient Vital Status
Patients alive or dead after 24 months from time of study entry
Time frame: Study entry up to 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Temsirolimus) | Patient Vital Status | Alive without disease progression | 5 participants |
| Treatment (Temsirolimus) | Patient Vital Status | Alive with disease progression | 19 participants |
| Treatment (Temsirolimus) | Patient Vital Status | Dead from disease | 29 participants |
| Treatment (Temsirolimus) | Patient Vital Status | Dead from neither treatment nor disease | 1 participants |
Other Pre-specified
Reason Off Study Therapy
Time frame: from study entry until end of study treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Temsirolimus) | Reason Off Study Therapy | Disease Progression | 37 participants |
| Treatment (Temsirolimus) | Reason Off Study Therapy | Refused Further Treatment | 5 participants |
| Treatment (Temsirolimus) | Reason Off Study Therapy | Toxicity as permitted | 8 participants |
| Treatment (Temsirolimus) | Reason Off Study Therapy | Other | 3 participants |
| Treatment (Temsirolimus) | Reason Off Study Therapy | Unspecified | 1 participants |