Combination Chemotherapy In Treating Patients With Advanced Cancer

NCT00003925 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000067112P30CA022453WSU-D-1641WSU-04-28-98-M02-FBNCI-G99-1526
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

gemcitabine hydrochloride DRUG

leucovorin calcium DRUG

tegafur-uracil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (2)

• El-Rayes BF, Zalupski M, Shields AF, Manza SG, LoRusso P, Philip PA. A phase I study of gemcitabine and uracil-ftorfar (UFT)/leucovorin. Am J Clin Oncol. 2007 Apr;30(2):101-5. doi: 10.1097/01.coc.0000251223.98193.f4.

  PMID: 17414457 RESULT

• Philip PA, Ibrahim D, Zalupski M, Arlauskas P, Shields A. Gemcitabine and UFT plus oral calcium folinate: phase I study. Oncology (Williston Park). 1999 Jul;13(7 Suppl 3):116-9.

  PMID: 10442378 RESULT

MeSH Terms

Interventions

Gemcitabine; Leucovorin; Tegafur

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Fluorouracil; Uracil; Pyrimidinones

Study Officials

• Philip A. Philip, MD, PhD, FRCP

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 2, 2003
• Study Start: May 1, 1998
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

US (1)