Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

This is an interventional treatment trial for Fallopian Tube Cancer Read More

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)