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Weekly Topotecan Therapy in Patients With Ovarian Cancer

This study has been terminated.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00194935
First received: September 13, 2005
Last updated: September 12, 2006
Last verified: September 2006
History of Changes
  Purpose
The purpose of this study is to find out the safety and feasibility of weekly topotecan consolidation therapy in patients with ovarian cancer.

Condition Intervention Phase
Ovarian Cancer
 Drug: Topotecan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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:
  • 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.
Estimated Enrollment: 32
Study Start Date: February 2003
Estimated Study Completion Date: August 2006
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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

ClinicalTrials.gov Identifier: NCT00194935     History of Changes
Other Study ID Numbers: 0103-636 
Study First Received: September 13, 2005
Last Updated: September 12, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016