Phase 2
N=60
Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Cancer · Primary Peritoneal Cavity Cancer · Recurrent Ovarian Epithelial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00429793 ↗Enrolled (actual)
60
Serious AEs
9.3%
Results posted
Nov 2013
Primary outcome: Primary: 6 Month Progression-free Survival (PFS) — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temsirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Progression-free Survival (PFS) |
13 | — |
| PRIMARY Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria |
5; 22; 21; 6 | — |
| PRIMARY Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) |
14; 14; 0; 0; 0; 18 | — |
| SECONDARY Duration of Progression-free Survival |
3.19 | — |
| SECONDARY Duration of Overall Survival |
11.60 | — |
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 grade 2
- Fasting cholesterol 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)
Data sourced from ClinicalTrials.gov (NCT00429793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.