Clinical trial · Interventional
Combination Chemotherapy In Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase I Study of Oxaliplatin, CPT-11, 5-FU and Leucovorin in Patients With Solid Tumors
NCT00005068CI-TRIAL-00005310completedPhase 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 determine the effectiveness of two different regimens of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable solid tumor for which no standard or curative therapy exists No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST no greater than 5 times ULN Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmias No New York Heart Association class III or IV heart disease Neurologic: No peripheral neuropathy grade 2 or greater No uncontrolled seizure disorders Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled concurrent illness No active infection No history of allergy to platinum compounds, irinotecan, antiemetics, or antidiarrheals PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No greater than 3 prior chemotherapy regimens for metastatic disease No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy At least 4 weeks since other prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: No concurrent antiretroviral therapy for HIV positive patients
References
Publications (1)
- RESULTGoetz MP, Erlichman C, Windebank AJ, Reid JM, Sloan JA, Atherton P, Adjei AA, Rubin J, Pitot H, Galanis E, Ames MM, Goldberg RM. Phase I and pharmacokinetic study of two different schedules of oxaliplatin, irinotecan, Fluorouracil, and leucovorin in patients with solid tumors. J Clin Oncol. 2003 Oct 15;21(20):3761-9. doi: 10.1200/JCO.2003.01.238. Epub 2003 Sep 8. PMID 12963697