Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490711
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 21, 2007
June 21, 2007
July 2003
Not Provided
Overall response rate
Same as current
No Changes Posted
  • Progression-free survival
  • 2-year survival
  • Toxicity
  • Dose intensity
Same as current
Not Provided
Not Provided
 
Treatment of Paclitaxel Plus Carboplatin Followed by Gemcitabine Plus Carboplatin for Patients With Epithelial Ovarian Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epithelial Ovarian Cancer
  • Drug: gemcitabine
  • Drug: carboplatin
  • Drug: paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
April 2005
Not Provided

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT00490711
4720, B9E-MC-S205
No
Not Provided
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2007

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