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Completed

NCT Number: NCT00191334

Gemcitabine in Ovarian Cancer

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary 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., Irkutsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No prior chemotherapy or radiation therapy

Treatment and study plan

Gemcitabine

Drug

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

Cisplatin

Drug

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

Primary outcomes

  1. Best Overall Tumor Response

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

    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).

Secondary outcomes

  1. Duration of Response

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

    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

  2. Time to Progressive Disease

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

    Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.

  3. Time to Treatment Failure

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

    Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.

  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

    Grades range from 0 (no toxicity) to 4 (life-threatening or disabling).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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