Status:
COMPLETED
Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Gynecologic Oncology Group
Conditions:
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 peritone...
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 periton...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00429793
Start Date
February 1 2007
End Date
January 1 2012
Last Update
July 24 2019
Active Locations (1)
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1
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103