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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Camptothecin; Capecitabine; Irinotecan

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

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