A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC #683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
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)