Phase 2
N=81
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Cancer · Ovarian Cancer · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00114166 ↗Enrolled (actual)
81
Serious AEs
22.5%
Results posted
Jun 2014
Primary outcome: Primary: Objective Tumor Response — 4; 8; 8; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- topotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response |
4; 8; 8; 32; 2; 21 | — |
| PRIMARY Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 |
10; 6; 7; 6; 14; 18 | — |
| SECONDARY Reason Off Study Therapy |
9; 47; 3; 7; 3; 2 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.
PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
- Recurrent disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion not in a previously irradiated field
- Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
- Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel
- Platinum-sensitive disease
- Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sensory or motor neuropathy > grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic agents for the malignancy
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
- No concurrent cytokines during the first course of study treatment
- No concurrent pegfilgrastim
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- Recovered from prior chemotherapy
- No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
- No prior topotecan
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of marrow-bearing areas
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for the malignancy
- No prior anticancer therapy that would preclude study treatment
Data sourced from ClinicalTrials.gov (NCT00114166). 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.