Weekly Topotecan Therapy in Patients With Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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Ovarian Cancer Cancer of the Ovary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Thomas Caputo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medcial College of Cornell University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0103-636

Identifier Type: -

Identifier Source: org_study_id