Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Pharmaceutical / Industry	ROCHE-ML16323 NCT00022698

Objectives

1. Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.
2. Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen.
3. Determine the 1-year survival and overall survival of patients treated with this regimen.
4. Determine the toxicity and safety profile of this regimen in these patients.
5. Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.

Entry Criteria

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

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 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 65 patients will be accrued for this study within 9 months.

Outline

This is a multicenter study.

Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months.

Meropol NJ, Gold PJ, Diasio RB, et al.: Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 24 (25): 4069-77, 2006.[PUBMED Abstract]

Carlini LE, Meropol NJ, Bever J, et al.: UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res 11 (3): 1226-36, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Hoffmann-La Roche, Incorporated

Mike Andria, Protocol chair		Ph: 973-235-5000; 800-526-6367

Registry Information
Official Title		A Phase II Study of Oral Xeloda in Combination with Intravenous Irinotecan for Patients with Locally Advanced and/or Metastatic Colorectal Cancer
Trial Start Date		2001-03-28
Registered in ClinicalTrials.gov		NCT00022698
Date Submitted to PDQ		2001-07-03
Information Last Verified		2005-02-11

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