Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Mayo Clinic
- Study ID
- NCT00436644
- Phase
- PHASE2
- Status
- Completed
Conditions
- Ovarian Cancer
- Peritoneal Cavity Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib — DRUG1250 mg orally days 1 -28.
- Topotecan — DRUG3.2 mg/m2 IV over 30 min in 100mL D5W (5% dextrose in water) or 0.9% NS at days 1, 8 \& 15.
Study Details
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 lapatinib together with topotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin.
Key Dates
- Start date
- Mar 31, 2007
- Status verified
- Mar 2014
- Primary completion
- Mar 31, 2009
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Lapatinib + TopotecanAssess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
Primary Outcome Measure
Response Rate (Complete Response (CR) or Partial Response (PR)) [ Time Frame: Two consecutive evaluations at least 4 weeks apart ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85254 | - |
| Mayo Clinic in Jacksonville | Jacksonville | Florida | 32224 | - |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | - |
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