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Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial 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: NCT00490711
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 21, 2007
First Posted Date  ICMJE June 25, 2007
Last Update Posted Date June 25, 2007
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
Overall response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
  • Progression-free survival
  • 2-year survival
  • Toxicity
  • Dose intensity
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 Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
Official Title  ICMJE Phase II Study of Sequential Therapy With Paclitaxel Plus Carboplatin Followed by Gemzar Plus Carboplatin in the Treatment of Patients With Epithelial Ovarian Cancer FIGO Stages III-IV
Brief Summary The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.
Detailed Description Not Provided
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 Epithelial Ovarian Cancer
Intervention  ICMJE
  • Drug: gemcitabine
  • Drug: carboplatin
  • Drug: paclitaxel
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2007)
7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically verified epithelial ovarian cancer
  • FIGO stage III-IV
  • Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment.
  • Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.

Exclusion Criteria:

  • Ovarian tumors with low malignant potential (borderline tumors)
  • Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors)
  • Time between definitive surgery and enrollment into the study is greater than 6 weeks
  • Patients who have received previous chemotherapy or radiotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (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 Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00490711
Other Study ID Numbers  ICMJE 4720
B9E-MC-S205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date June 2007

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