Combination Chemotherapy In Treating Patients With Advanced Cancer
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin |
| Estimated Enrollment: | 36 |
| Study Start Date: | May 1998 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated doses of gemcitabine, fluorouracil-uracil (UFT), and leucovorin calcium in patients with advanced refractory cancer.
- Assess the toxicity of this combination regimen in this patient population.
- Evaluate this regimen in terms of response rate, response duration, and overall survival in these patients.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignancy refractory to existing chemotherapy or for which no standard therapy exists
- Evaluable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 8.0 mg/dL
Hepatic:
- Bilirubin less than 2.0 mg/dL
- AST less than 3.0 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- No active infection requiring antibiotics
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior systemic cytotoxic chemotherapy (including fluorouracil) and recovered
- No prior gemcitabine
Endocrine therapy:
- Prior hormonal therapy allowed
- No concurrent hormonal contraception
Radiotherapy:
- At least 3 weeks since prior radiotherapy to large areas of active bone marrow and recovered
Surgery:
- Prior major surgery allowed and recovered
Other:
- No prior or concurrent antiviral nucleosides
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003925 History of Changes |
| Other Study ID Numbers: | CDR0000067112, P30CA022453, WSU-D-1641, WSU-04-28-98-M02-FB, NCI-G99-1526 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Tegafur Gemcitabine Leucovorin Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013