Gemcitabine in Ovarian Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: gemcitabine Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 50 |
| Study Start Date: | December 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
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:
Drug: cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ECOG = 0-2
- Operated patients
- disease stage III-IV
Exclusion Criteria:
- No prior chemotherapy or radiation therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191334
Locations
| 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, Russian Federation | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00191334 History of Changes |
| Other Study ID Numbers: | 9340, B9E-MW-S368 |
| Study First Received: | September 12, 2005 |
| Results First Received: | December 17, 2008 |
| Last Updated: | February 24, 2009 |
| Health Authority: | Russia: Pharmacological Committee, Ministry of Health |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013