Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
NCT00059865 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2016-12-07
Summary
RATIONALE: Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die. Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining gemcitabine with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with pemetrexed disodium to see how well it works in treating patients with unresectable or metastatic biliary tract or gallbladder cancer.
Conditions
- Extrahepatic Bile Duct Cancer
- Gallbladder Cancer
- Liver Cancer
Interventions
- DRUG
-
gemcitabine hydrochloride
- DRUG
-
pemetrexed disodium
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Steven R. Alberts, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-31
- Primary Completion
- 2007-02-28
- Completion
- 2008-02-29
Countries
- United States
Study Locations
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