Gemcitabine in Ovarian Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer

U.S. FDA Resources

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: LY188011 Gemzar 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

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, see Learn About Clinical Studies.

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

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 Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Neoplasms Gemcitabine Anti-Infective Agents	Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Antiviral Agents Enzyme Inhibitors Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015