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Weekly Topotecan Therapy in Patients With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00194935
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 13, 2006
Sponsor:
Information provided by:
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Topotecan Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
Study Start Date : February 2003
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194935


Locations
United States, New York
Weill Medcial College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Thomas Caputo, M.D. Weill Medical College of Cornell University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00194935     History of Changes
Other Study ID Numbers: 0103-636
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006

Keywords provided by Weill Medical College of Cornell University:
Ovarian Cancer
Cancer of the Ovary

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents