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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00380588
Recruitment Status : Completed
First Posted : September 26, 2006
Results First Posted : November 19, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: gemcitabine Drug: cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer
Study Start Date : September 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
Experimental: Gemcitabine + Cisplatin

Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Drug: gemcitabine
1000 milligrams per square meter (mg/m2), intravenous (IV)
Other Names:
  • LY188011
  • Gemzar

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

Experimental: Gemcitabine
Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Drug: gemcitabine
1000 milligrams per square meter (mg/m2), intravenous (IV)
Other Names:
  • LY188011
  • Gemzar




Primary Outcome Measures :
  1. Percentage of Patients Alive at 1 Year (1-Year Survival Rate) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: baseline to measured progressive disease (up to 2 years) ]
  2. Progression Free Survival [ Time Frame: baseline to measured progressive disease (up to 2 years) ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT00380588


Locations
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Japan
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, 466-8560
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.
Chiba, Japan, 277-8577
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.
Fukuoka, Japan, 811-1395
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.
Hokkaido, Japan, 060-8648
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.
Kanagawa, Japan, 241-0815
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.
Shizuoka, Japan, 411-8777
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.
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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:
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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00380588     History of Changes
Other Study ID Numbers: 10298
B9E-JE-BT22
First Posted: September 26, 2006    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Cisplatin
Gemcitabine
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