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Weekly Topotecan Therapy in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00194935
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : September 13, 2006
Information provided by:
Weill Medical College of Cornell University

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.

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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

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00194935

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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
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Principal Investigator: Thomas Caputo, M.D. Weill Medical College of Cornell University
Layout table for additonal information Identifier: NCT00194935    
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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents