Clinical trial NCT00429793 (phase 2, status: completed)
Conditions: fallopian tube cancer, primary peritoneal cavity cancer, recurrent ovarian epithelial cancer
ICD codes: C57.00, C57.01, C57.02, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818, H18.523, H18.521, H18.522, H18.529
Drugs: temsirolimus
SMILES: CN1N=NC2=C(N=CN2C1=O)C(N)=O
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)