Recurrent Endometrial Carcinoma
Conditions
Brief summary
This phase II trial is studying the side effects of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving bevacizumab together with temsirolimus may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer. II. To determine the nature and degree of toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. To determine the duration of PFS and overall survival of patients treated with this regimen. II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen. TERTIARY OBJECTIVES: I. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV 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 therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.
Interventions
BIOLOGICALbevacizumab
Given IV
DRUGtemsirolimus
Given IV
Sponsors
NRG Oncology
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 (from primary tumor) including any of the following cell types: * Endometrioid adenocarcinoma * Serous adenocarcinoma * Undifferentiated carcinoma * Clear cell adenocarcinoma * Mixed epithelial carcinoma * Adenocarcinoma not otherwise specified * Mucinous adenocarcinoma * Squamous cell carcinoma * Transitional cell carcinoma * Mesonephric carcinoma * Recurrent or persistent disease that is 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 * Must have ≥ 1 target lesion to assess response as defined by RECIST * Tumors within a previously irradiated field are designated as non-target lesions in the absence of documented disease progression or a biopsy to confirm persistence for ≥ 90 days after completion of radiotherapy * Must have received 1 prior chemotherapeutic regimen for management of endometrial carcinoma * May have received 1 additional cytotoxic regimen for management of this disease * Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, including any active GOG Phase III protocol for patients with endometrial carcinoma * No history or evidence of CNS disease, including primary brain tumor or any brain metastases upon physical examination * GOG performance status (PS) 0-2 (for patients who have received 1 prior regimen) OR PS 0-1 (for patients who have received 2 prior regimens) * ANC ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * 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 * Urine protein:creatinine ratio \< 1.0 OR urine protein \< 1,000 mg by 24-hour urine collection * INR ≤ 1.5 OR in-range INR between 2 and 3 if patient is on a stable dose of therapeutic warfarin * PTT ≤ 1.5 times ULN * Fasting cholesterol \< 350 mg/dL * Fasting triglycerides \< 400 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Seizures allowed provided they are controlled with standard medical therapy * No active infection requiring antibiotics, except uncomplicated urinary tract infection * No active bleeding or pathologic conditions that carry high risk of bleeding, (e.g., known bleeding disorder, coagulopathy, or tumor involving major vessels) * No serious, non-healing wound, ulcer, or bone fracture, including abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 3 months * No prior underlying lesions that caused the fistula or perforation that have not been corrected * No prior interstitial pneumonitis * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg * Myocardial infarction or unstable angina within the past 6 months * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Peripheral vascular disease ≥ grade 2 * No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months * No uncontrolled diabetes * Hemoglobin A1C \< 10 * No other invasive malignancies within the past 5 years, except nonmelanoma skin cancer and other specific malignancies (e.g., localized breast, head and neck, or skin cancer that completed treatment \> 3 years prior to study and remain disease-free) * No significant traumatic injury within the past 28 days * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Concurrent prophylactic or therapeutic anticoagulation\* (e.g., warfarin) allowed * Recovered from recent surgery, radiotherapy, or chemotherapy * No prior bevacizumab or other VEGF pathway-targeted therapy * No prior temsirolimus, everolimus, deforolimus, sirolimus, or any other mTor/PI3K pathway-targeted therapy * No prior non-cytotoxic chemotherapy for management of this disease, except hormonal therapy * At least 1 week since prior hormonal therapy directed at the malignant tumor * No prior therapy that contraindicates this protocol therapy * No prior radiotherapy to any portion of the abdominal cavity or pelvis within the past 5 years, except treatment of endometrial cancer * Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed, provided it was completed \> 3 years prior to study entry and patient remains free of recurrent or metastatic disease * No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years, except treatment of endometrial cancer * Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed \> 3 years prior to study entry and the patient remains free of recurrent or metastatic disease * Prior treatment with an anthracycline (i.e., doxorubicin and/or liposomal doxorubicin) allowed provided ejection fraction \< 50% * More than 28 days since prior major surgery or open biopsy * More than 7 days since minor surgical procedures, fine needle aspirates, or core biopsies * At least 3 weeks since prior therapy directed at the malignant tumor, including immunologic agents * No concurrent major surgery * No concurrent prophylactic filgrastim (G-CSF) or thrombopoietic agents * No concurrent amifostine or other protective reagents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 |
| Progression-free Survival at 6 Months | Every other cycle for 6 months | Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Every cycle and 30 days after the last treatment, an average of 5 years. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival at 6 Months by Performance Status | Every other cycle for 6 months | Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type | Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | Complete and Partial Tumor Response by RECIST 1.0 |
| Progression-Free Survival | Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. | Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade | Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | Complete and Partial Tumor Response by RECIST 1.0 |
| Progression-free Survival at 6 Months by Tumor Grade | Every other cycle for 6 months | Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Progression-free Survival at 6 Months by Histologic Type | Every other cycle for 6 months | Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Overall Survival | From entry into the study to death or the date of last contact, up to 5 years | The observed length of life from entry into the study to death or the date of last contact. |
| Complete and Partial Tumor Response by RECIST 1.0 by Performance Status | Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | Complete and Partial Tumor Response by RECIST 1.0 |
Countries
United States
Participant flow
Recruitment details
The study was activated on 9/8/2008 and closed to accrual on 3/22/2010 (and was suspended from 1/19/2009 to 12/7/2009).
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Plus Temsirolimus Bevacizumab 10 mg/kg IV every other week plus Temsirolimus 25 mg IV weekly (one cycle = 4 weeks) until disease progression or adverse effects prohibit further therapy | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible: Inadequate pathology | 1 |
| Overall Study | Ineligible: Second primary | 1 |
| Overall Study | Ineligible: Wrong Primary | 2 |
Baseline characteristics
| Characteristic | Bevacizumab Plus Temsirolimus |
|---|---|
| Age, Customized 20-29 years | 0 participants |
| Age, Customized 30-39 years | 1 participants |
| Age, Customized 40-49 years | 4 participants |
| Age, Customized 50-59 years | 11 participants |
| Age, Customized 60-69 years | 21 participants |
| Age, Customized 70-79 years | 11 participants |
| Age, Customized 80-89 years | 1 participants |
| Sex: Female, Male Female | 49 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 | 49 / 49 |
| serious Total, serious adverse events | 31 / 49 |
Outcome results
Primary
Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: Every cycle and 30 days after the last treatment, an average of 5 years.
Population: Eligible and evaluable patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 45 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 18 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 41 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 46 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 48 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 20 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 12 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 43 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 26 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 47 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 28 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 5 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 43 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 9 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 40 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 33 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 48 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 18 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 24 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 34 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 14 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 48 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 47 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 48 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 25 Participants |
| Bevacizumab Plus Temsirolimus | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 44 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 9 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 11 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 13 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 18 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 14 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 12 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 17 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 13 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 11 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 22 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 9 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 12 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 15 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 14 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 18 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 16 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 15 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 10 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 17 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 5 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 6 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 9 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 14 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 8 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 5 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 3 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Genitourinary/renal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Metabolic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Endocrine | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pain | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Coagulation | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Lymphatics | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Allergy/immunology | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Cardiac | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Pulmonary | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Infection | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Gastrointestinal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Anemia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Sexual/reproductive | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other neurological | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neurosensory | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Vascular | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Death, not CTC coded | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Ocular/visual | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | Other hematologic | 0 Participants |
Primary
Progression-free Survival at 6 Months
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Every other cycle for 6 months
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Progression-free Survival at 6 Months | 46.9 percentage of participants |
Primary
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Tumor Response | 24.5 percentage of participants |
Secondary
Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type
Complete and Partial Tumor Response by RECIST 1.0
Time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type | 21 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type | 33 percentage of participants |
Secondary
Complete and Partial Tumor Response by RECIST 1.0 by Performance Status
Complete and Partial Tumor Response by RECIST 1.0
Time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Complete and Partial Tumor Response by RECIST 1.0 by Performance Status | 24 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Complete and Partial Tumor Response by RECIST 1.0 by Performance Status | 25 percentage of participants |
Secondary
Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade
Complete and Partial Tumor Response by RECIST 1.0
Time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade | 30 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade | 18 percentage of participants |
Secondary
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: From entry into the study to death or the date of last contact, up to 5 years
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Overall Survival | 16.9 Months |
Secondary
Progression-Free Survival
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Progression-Free Survival | 5.6 Months |
Secondary
Progression-free Survival at 6 Months by Histologic Type
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Every other cycle for 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Progression-free Survival at 6 Months by Histologic Type | 44 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Progression-free Survival at 6 Months by Histologic Type | 53 percentage of participants |
Secondary
Progression-free Survival at 6 Months by Performance Status
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Every other cycle for 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Progression-free Survival at 6 Months by Performance Status | 48 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Progression-free Survival at 6 Months by Performance Status | 45 percentage of participants |
Secondary
Progression-free Survival at 6 Months by Tumor Grade
Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Every other cycle for 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab Plus Temsirolimus | Progression-free Survival at 6 Months by Tumor Grade | 60 percentage of participants |
| Grade 1 (CTCAE v 3.0) | Progression-free Survival at 6 Months by Tumor Grade | 32 percentage of participants |