Weekly Topotecan Therapy in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00194935
• Other study ID #: 0103-636
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 12, 2006
• Start date: February 2003
• Est. completion date: August 2006

Study information

• Verified date: September 2006
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Topotecan

Locations

Country	Name	City	State
United States	Weill Medcial College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
Secondary	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.