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Gemcitabine in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00191334
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 27, 2009
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

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 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
Primary Completion Date : December 2007
Study Completion Date : December 2007


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



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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    Key Record Dates
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