Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Intervention: temsirolimus
Intervention description: Given IV
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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)