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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00660140 |
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.
Condition | Intervention | Phase |
---|---|---|
Cholangiocarcinoma Gallbladder Cancer |
Drug: Gemcitabine + Carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Gemcitabine and Carboplatin in the Treatment of Metastatic or Recurrent Cholangiocarcinoma/Gallbladder Cancer |
Enrollment: | 49 |
Study Start Date: | March 2002 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Gemcitabine at 1000 mg/m2 intravenously over 30 minutes on days 1 and 8 of a 21 day cycle
Followed by
Carboplatin at AUC of 5 intravenously over 60 minutes on day 1 of a 21 day cycle
To determine the activity of gemcitabine combined with carboplatin in the treatment of patients with metastatic or recurrent cholangiocarcinoma or gallbladder cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Initial Required Laboratory Values:
Exclusion Criteria:
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Benjamin Tan, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Benjamin Tan ) |
Study ID Numbers: | 01-0925 |
Study First Received: | April 11, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00660140 |
Health Authority: | United States: Institutional Review Board |
Cholangiocarcinoma Gallbladder Cancer |
Gallbladder Diseases Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms Carboplatin Recurrence Carcinoma Gall bladder cancer |
Digestive System Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Gallbladder Neoplasms Gemcitabine Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |