Gemcitabine in Ovarian Cancer

NCT00191334 | Completed Phase 2 Results

• 2 other identifiers: 9340B9E-MW-S368
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall Tumor Response

  Best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

  every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up

Secondary Outcomes (4)

• Duration of Response

  every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

• Time to Progressive Disease

  every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

• Time to Treatment Failure

  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

  every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up

Study Arms (1)

A

EXPERIMENTAL

Drug: gemcitabine; Drug: cisplatin

Interventions

gemcitabine DRUG

1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity

Also known as: LY188011, Gemzar

A

cisplatin DRUG

75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG = 0-2
• Operated patients
• disease stage III-IV

You may not qualify if:

• No prior chemotherapy or radiation therapy

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

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, Russia

Location

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, Russia

Location

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, Russia

Location

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.

Saint Petersburg, Russia

Location

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, Russia

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: December 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 27, 2009
• Results First Posted: March 27, 2009

Record last verified: 2009-02

Locations

RU (5)