Clinical trial · Interventional
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
- 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, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
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 |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Time to progression
- measure
- Time to death from progression
Secondary outcomes (6)
- measure
- Objective response
- measure
- Stabilization rate
- measure
- Time to treatment failure
- measure
- Duration of response
- measure
- Overall survival rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal adenocarcinoma * Metastatic, unresectable disease * Meets 1 of the following criteria: * At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan * Evaluable disease * Evidence of disease (e.g., ascites or bone metastases) by imaging techniques * Progressive disease as defined by 1 of the following criteria: * Progressive disease while receiving first-line chemotherapy * Recurrent disease within 6 months after completing adjuvant chemotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * WHO 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * Alkaline phosphatase \< 3 times ULN Renal * Not specified Cardiovascular * No uncontrolled angina * No myocardial infarction within the past 6 months Gastrointestinal * No chronic diarrhea grade 2 or greater * No unresolved fully or partially obstructed intestine Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other underlying disease or medical condition that would preclude study participation * No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix * No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior irinotecan Endocrine therapy * Not specified Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * At least 3 weeks since prior surgery Other * No other concurrent clinical trial participation
References
Publications (0)
Data not yet available