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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003925 |
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-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride Drug: leucovorin calcium Drug: tegafur-uracil |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin |
Estimated Enrollment: | 36 |
Study Start Date: | May 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of gemcitabine and fluorouracil-uracil.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Patients receive oral leucovorin calcium immediately followed by oral fluorouracil-uracil (UFT) three times a day on days 1-21. Courses are repeated every 28 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and UFT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 36 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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 |
Study Chair: | Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000067112, WSU-D-1641, WSU-04-28-98-M02-FB, NCI-G99-1526 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003925 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Calcium, Dietary Tegafur Leucovorin Gemcitabine |
Antimetabolites Anti-Infective Agents Vitamin B Complex Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Radiation-Sensitizing Agents Vitamins Therapeutic Uses Micronutrients |