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OpenTrials
Completed

NCT Number: NCT00380588

Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this 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., Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histological or cytological diagnosis of biliary tract cancer
  • Measurable disease must be at least one lesion
  • Chemotherapy-naïve
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Estimated life expectancy no less than 3 months

Exclusion criteria

  • radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia

Treatment and study plan

Gemcitabine

Drug

1000 milligrams per square meter (mg/m2), intravenous (IV)

Other names: LY188011, Gemzar

Cisplatin

Drug

25 milligrams per square meter (mg/m2), intravenous (IV)

Primary outcomes

  1. Percentage of Patients Alive at 1 Year (1-Year Survival Rate)

    Time frame: 1 year

    Percentage of patients alive at 1 year.

Secondary outcomes

  1. Tumor Response

    Time frame: baseline to measured progressive disease (up to 2 years)

    Response Evaluation Criteria In Solid Tumors - define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria.

  2. Progression Free Survival

    Time frame: baseline to measured progressive disease (up to 2 years)

    The period from study entry until disease progression, death or date of last contact.

Other outcomes

  1. Survival Time

    Time frame: baseline to date of death due to any cause (up to 2 years)

    Data of patients lost to follow-up were censored at the last date of confirmation of their survival.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 26, 2006
Registry last updated
Nov 20, 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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