Expired Study
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New York, New York 10021


Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

0103-636


NCT ID:

NCT00194935


Secondary ID:


Study Acronym:


Brief Title:

Weekly Topotecan Therapy in Patients With Ovarian Cancer


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:


Overall Contact Information

Official Name:Thomas Caputo, M.D.
Principal Investigator
Weill Medical College of Cornell University

Study Dates

Start Date:February 2003
Completion Date:August 2006
Verification Date:September 2006
Last Changed Date:September 12, 2006
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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.
Safety Issues:False
Outcome Type:Primary 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.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Topotecan

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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