Clinical trial · Interventional
Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive, Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With 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 irinotecan and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive, metastatic colorectal cancer that cannot be removed by surgery.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Objective response
- measure
- Stable disease rate
Secondary outcomes (3)
- measure
- Tolerability
- measure
- Quality of life
- measure
- Progression-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum * Unresectable disease * Documented progressive disease during first-line/palliative chemotherapy * Measurable disease ≥ 1 cm that is outside prior radiation field * No brain metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy ≥ 3 months * No contraindication to chemotherapy * Creatinine clearance ≥ 40 mL/min * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement) * Bilirubin ≤ 1.5 times normal * Transaminases ≤ 5 times normal * No symptomatic coronary disease or cardiac insufficiency * No enteropathy or chronic diarrhea * No unresolved intestinal occlusion or subocclusion * No history of severe unexpected reaction to a fluoropyrimidine * No other active malignancy in the past 2 years * No hypersensitivity to irinotecan hydrochloride or its excipients * No hypersensitivity to capecitabine or fluorouracil PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior extensive resection * No concurrent sorivudine or similar analogs (e.g., brivudine) * No other concurrent anticancer therapy * Concurrent radiotherapy allowed for nontarget lesions
References
Publications (0)
Data not yet available