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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.
 
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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date September 13, 2006
Study Start Date  ICMJE February 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
The objective of this study is to evaluate the safety and feasibility of weekly topotecan consolidation therapy in patients with epithelial ovarian cancer.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00194935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weekly Topotecan Therapy in Patients With Ovarian Cancer
Official Title  ICMJE A Phase II Trial of Weekly Topotecan As Consolidation Therapy in Ovarian Cancer Patients After Initial Chemotherapy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: Topotecan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 13, 2005)
32
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194935
Other Study ID Numbers  ICMJE 0103-636
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Caputo, M.D. Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP