Clinical trial · Interventional
Combination Chemotherapy In Treating Patients With Advanced Cancer
Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
NCT00003925CI-TRIAL-00009932completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| tegafur-uracil | Drug | Tegafur | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTEl-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
- RESULTPhilip 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