Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Completed · Phase 2
Conditions studied: Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
In brief
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.
Key facts
- Study ID
- NCT00429793
- Run by
- National Cancer Institute (NCI)
- People needed
- 60
- Starts
- 2007-02-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2019-07-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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