Gemcitabine in Ovarian Cancer

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: gemcitabine; Drug: cisplatin	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer
Study Start Date :	December 2004
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Arm	Intervention/treatment
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: LY188011; Gemzar Drug: cisplatin; 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity

Outcome Measures

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Primary Outcome Measures :

1. Best Overall Tumor Response [ Time Frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up ]

Secondary Outcome Measures :

1. Duration of Response [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
2. Time to Progressive Disease [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
3. Time to Treatment Failure [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
4. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00191334 History of Changes
Other Study ID Numbers:	9340; B9E-MW-S368
First Posted:	September 19, 2005
Results First Posted:	March 27, 2009
Last Update Posted:	March 27, 2009
Last Verified:	February 2009

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; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs