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A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

Patients with Stage IIIC and IV optimally-debulked ovarian cancer will be treated with 6
cycles (every 3 weeks) of carboplatin (AUC 5) and paclitaxel (175 mg/m2). Patients who
demonstrate a complete clinical response to this regimen will then be treated with
topotecan consolidation (4 mg/m2 weekly x 8 weeks for one cycle followed by a break in the
9th week) for a maximum of 3 cycles. Primary endpoints will be toxicity and the
determination of the appropriate dose, schedule, and duration of topotecan for further
consolidation trials.

Inclusion Criteria:

- Patients must have a histopathologic diagnosis of epithelial ovarian cancer.

- Patients must have completed front-line chemotherapy and be clinically NED (CA 125
<35, negative CT scan, negative physical exam).

- Patients may have a second look laparoscopy, however, there must be no gross disease
present (microscopic disease or pathologically negative).

- Patients must not have had other myelosuppressive therapy within four weeks of
initiating topotecan therapy.

- Topotecan treatment must begin within 10 weeks following last cycle of initial

- Patients may have had only one prior chemotherapy regimen.

Exclusion Criteria:

- Patients with a concomitant malignancy other than squamous cell or basal cell skin

- Patients who are pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.

Principal Investigator

Thomas Caputo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

August 2006

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Cancer of the Ovary
  • Ovarian Neoplasms



Weill Medcial College of Cornell UniversityNew York, New York  10021