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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019513 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil, and leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or lymphomas.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Esophageal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Lung Cancer Lymphoma Pancreatic Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients |
Estimated Enrollment: | 108 |
Study Start Date: | August 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of fluorouracil and gemcitabine.
During the first course, patients receive gemcitabine IV over 30 minutes once weekly for 2 weeks followed by one week of rest. During subsequent courses, patients receive gemcitabine as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks. Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of fluorouracil is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of fluorouracil and then gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 108 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:
Diagnosis of cancer that has failed standard therapy or for which no such therapy exists, including, but not limited to:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Eva Szabo, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000066587, NCI-98-C-0143 |
Study First Received: | July 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00019513 History of Changes |
Health Authority: | United States: Federal Government |
stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma anaplastic large cell lymphoma stage IV mycosis fungoides/Sezary syndrome |
Thoracic Neoplasms Gallbladder Diseases Anti-Infective Agents Liver Diseases Lymphoma, Mantle-Cell Pancreatic Neoplasms Colonic Diseases Mantle Cell Lymphoma Follicular Lymphoma Ileal Diseases Rectal Diseases Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms |
Lymphoma, Large-Cell, Anaplastic Gemcitabine Hodgkin Disease Endocrine Gland Neoplasms Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Endocrine System Diseases Esophageal Cancer Carcinoma Carcinoma, Small Cell B-cell Lymphomas Esophageal Disorder Bile Duct Diseases Fluorouracil |
Gallbladder Diseases Thoracic Neoplasms Anti-Infective Agents Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Pancreatic Neoplasms Physiological Effects of Drugs Colonic Diseases Rectal Diseases Ileal Diseases Duodenal Neoplasms Neoplasms by Site Lung Neoplasms Therapeutic Uses |
Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Immunoproliferative Disorders Immune System Diseases Endocrine System Diseases Neoplasms Bile Duct Diseases Lung Diseases Fluorouracil Gastrointestinal Neoplasms Pancreatic Diseases Esophageal Diseases Gallbladder Neoplasms Bile Duct Neoplasms |