Weekly Topotecan Therapy in Patients With Ovarian Cancer

NCT00194935TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Weill Medical College of Cornell University

Enrollment

32

Start Date

2003-02-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Topotecan

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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 chemotherapy.
* Patients may have had only one prior chemotherapy regimen.

Exclusion Criteria:

* Patients with a concomitant malignancy other than squamous cell or basal cell skin cancer.
* Patients who are pregnant or breast-feeding.

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

To determine the efficacy (Progression free survival) of weekly topotecan as consolidation therapy in ovarian cancer patients who are clinically NED or have microscopic disease only after first-line chemotherapy.

Locations

Weill Medcial College of Cornell University, New York, United States

Weekly Topotecan Therapy in Patients With Ovarian Cancer