Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
A Randomized Phase II Trial Of Capecitabine And Different Schedules Of Irinotecan As First Line Treatment For Advanced Or Metastatic Colorectal Cancer
NCT00030797CI-TRIAL-00006915completedPhase 2ClinicalTrials.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: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan 240 mg/m2 | Drug | Irinotecan | ALIAS |
| Irinotecan 70 mg/m2 | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
- interventionNames
- Drug: Irinotecan 70 mg/m2
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Irinotecan i.v. 240 mg/m2 day 1 and day 22; Capecitabine p.o. 2 x 1000 mg/m2, d1-14, d22-35;
- interventionNames
- Drug: Irinotecan 240 mg/m2
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic colorectal cancer * Unresectable disease * At least 1 bidimensionally measurable lesion * At least 2 cm in perpendicular diameters * No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * 0-1 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No New York Heart Association class III or IV heart disease * No symptomatic coronary artery disease * No uncontrolled cardiac arrhythmia * No myocardial infarction within the past year Gastrointestinal: * No evidence of dysphagia * No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs * No chronic diarrhea Other: * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer * No psychiatric disability that would preclude study compliance * No other significant medical condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for advanced or metastatic disease Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * At least 4 weeks since prior major surgery to the gastrointestinal tract Other: * No concurrent therapy for history of seizures or CNS disorder
References
Publications (1)
- RESULTBorner MM, Bernhard J, Dietrich D, Popescu R, Wernli M, Saletti P, Rauch D, Herrmann R, Koeberle D, Honegger H, Brauchli P, Lanz D, Roth AD; Swiss Group for Clinical Cancer Research (SAKK), Berne, Switzerland. A randomized phase II trial of capecitabine and two different schedules of irinotecan in first-line treatment of metastatic colorectal cancer: efficacy, quality-of-life and toxicity. Ann Oncol. 2005 Feb;16(2):282-8. doi: 10.1093/annonc/mdi047. PMID 15668285