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Gemcitabine in Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191334
First received: September 12, 2005
Last updated: February 24, 2009
Last verified: February 2009
History of Changes

September 12, 2005
February 24, 2009
December 2004
December 2007   (final data collection date for primary outcome measure)
Best Overall Tumor Response [ Time Frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up ] [ Designated as safety issue: No ]
- To assess the objective tumor response
Complete list of historical versions of study NCT00191334 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ] [ Designated as safety issue: No ]
  • Time to Progressive Disease [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ] [ Designated as safety issue: Yes ]
  • Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade [ Time Frame: every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ] [ Designated as safety issue: Yes ]
  • - duration of response
  • - time to progressive disease
  • - time to treatment failure
Not Provided
Not Provided
 
Gemcitabine in Ovarian Cancer
Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer

The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: gemcitabine
    1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
    Other Names:
    • LY188011
    • Gemzar
  • Drug: cisplatin
    75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
Experimental: A
Interventions:
  • Drug: gemcitabine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ECOG = 0-2
  • Operated patients
  • disease stage III-IV

Exclusion Criteria:

  • No prior chemotherapy or radiation therapy
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00191334
9340, B9E-MW-S368
No
Chief Medical Officer, Eli Lilly
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
February 2009

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