Clinical trial · Interventional
Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer
NCT00022698CI-TRIAL-00021761completedPhase 2Results postedClinicalTrials.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)
PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, 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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )
- description
- Participants will receive capecitabine (Xeloda) 1000 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
- interventionNames
- Drug: Capecitabine
- Drug: Irinotecan
- type
- EXPERIMENTAL
- label
- Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)
- description
- Participants will receive capecitabine 900 mg/m\^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m\^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma * At least 1 measurable lesion * At least 10 mm by spiral CT scan * At least 20 mm by conventional techniques * Bone metastases, ascites, or pleural effusions are not considered measurable disease * No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present) * No known Gilbert's disease Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 50 mL/min Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No symptomatic coronary artery disease * No cardiac arrhythmias uncontrolled with medication * No myocardial infarction within the past 12 months Gastrointestinal: * Able to swallow tablets * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome Other: * No prior unanticipated severe reaction to fluoropyrimidine therapy * No hypersensitivity to fluorouracil * No history of uncontrolled seizures or CNS disorders * No psychological illness or condition that would preclude study entry * No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy * No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer * No concurrent prophylactic hematopoietic growth factors Chemotherapy: * At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy * No prior chemotherapy for metastatic colorectal cancer * No prior therapy with irinotecan or capecitabine * No other concurrent cytotoxic agents Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery and recovered * No prior organ allograft Other: * At least 4 weeks since prior participation in an investigational drug study * No other concurrent investigational drugs
References
Publications (2)
- RESULTMeropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006 Sep 1;24(25):4069-77. doi: 10.1200/JCO.2005.05.2084. PMID 16943524
- RESULTCarlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36. PMID 15709193