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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00059865 |
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.
Condition | Intervention | Phase |
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Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Trial Of Gemcitabine And ALIMTA In Patients With Measurable Or Evaluable, Unresectable Or Metastatic Biliary Tract Carcinoma (Intrahepatic, Extrahepatic, Ampulla Or Vater) And Gallbladder Carcinoma |
Estimated Enrollment: | 85 |
Study Start Date: | January 2004 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter phase I dose-escalation study of gemcitabine followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically or cytologically confirmed cancers not amenable to treatment with combined chemotherapy and radiotherapy:
No CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Prior chemoembolization allowed provided the following are true:
Endocrine therapy
Radiotherapy
Prior radiofrequency ablation allowed provided the following are true:
Surgery
Other
Prior embolization allowed provided the following are true:
Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
Study ID Numbers: | CDR0000298862, NCCTG-N9943 |
Study First Received: | May 6, 2003 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00059865 |
Health Authority: | United States: Federal Government |
advanced adult primary liver cancer unresectable gallbladder cancer unresectable extrahepatic bile duct cancer adult primary cholangiocellular carcinoma |
Bile duct cancer, extrahepatic Gallbladder Diseases Cholangiocarcinoma Liver Diseases Biliary Tract Neoplasms Digestive System Neoplasms Liver neoplasms Gall bladder cancer Carcinoma Folic Acid |
Pemetrexed Liver Neoplasms Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |