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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    1250 mg orally days 1 -28.
  • Topotecan — DRUG
    3.2 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 + Topotecan
    Assess 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)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85254-
Mayo Clinic in JacksonvilleJacksonvilleFlorida32224-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

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