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
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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 |
Actual Primary Completion Date : | December 2007 |
Actual 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:
Drug: cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
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- Best Overall Tumor Response [ Time Frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up ]
- Duration of Response [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
- Time to Progressive Disease [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
- Time to Treatment Failure [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ECOG = 0-2
- Operated patients
- disease stage III-IV
Exclusion Criteria:
- No prior chemotherapy or radiation therapy

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
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 |
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 |