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NCT00191334 Clinical Trial

Gemcitabine in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:
Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00191334
Other study ID # 9340
Secondary ID B9E-MW-S368
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated February 24, 2009
Start date December 2004
Est. completion date December 2007

Study information
Verified date February 2009
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Russia: Pharmacological Committee, Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ECOG = 0-2

- Operated patients

- disease stage III-IV

Exclusion Criteria:

- No prior chemotherapy or radiation therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine
1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity
• cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity

Locations
Country Name City State
Russian Federation For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Irkutsk
Russian Federation For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ivanovo
Russian Federation For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Moscow
Russian Federation For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St. Petersburg
Russian Federation For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stavropol

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Overall Tumor Response every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up No
Secondary Duration of Response every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up No
Secondary Time to Progressive Disease every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up No
Secondary Time to Treatment Failure every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up Yes
Secondary Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up Yes
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