Clinical trial · Interventional
Combination Chemotherapy in Treating Patients Who Have Advanced Solid Tumors
A Phase I & Pharmacologic Trial Of Sequential Irinotecan As A 24-Hour IV Infusion, Leucovorin, & Flurouracil As A 48-Hour IV Infusion In Adult Cancer Patients
NCT00020488CI-TRIAL-00017721completedPhase 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 combination chemotherapy in treating patients who have advanced 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 |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor that has failed standard therapy or for which no standard therapy exists * Locally advanced, unresectable, primary or recurrent disease OR * Metastatic disease * Previously untreated disease allowed provided this regimen represents reasonable first-line therapy * No leukemia or lymphoma * No primary CNS malignancy or CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.6 mg/dL * AST/ALT no greater than 4 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other serious concurrent illness that would preclude study * No active infection requiring IV antibiotics * No known hypersensitivity to irinotecan * No marked intolerance to fluorouracil PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 4 weeks since prior immunotherapy and recovered Chemotherapy: * More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered * Prior short-infusion irinotecan allowed * Prior fluorouracil allowed Endocrine therapy: * Not specified Radiotherapy: * At least 2 weeks since prior radiotherapy and recovered * At least 8 weeks since prior strontium chloride Sr 89 Surgery: * Recovered from prior surgery Other: * No concurrent cimetidine
References
Publications (0)
Data not yet available
No reference posted for this study.