Irinotecan With or Without Panitumumab or Cyclosporine in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Fluorouracil

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cyclosporine may help irinotecan work better by making tumor cells more sensitive to the drug. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether irinotecan is more effective when given with or without panitumumab or cyclosporine in treating colorectal cancer.

PURPOSE: This randomized phase III trial is studying irinotecan to compare how well it works when given with or without panitumumab or cyclosporine in treating patients with advanced or metastatic colorectal cancer that did not respond to fluorouracil.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Antibodies, Monoclonal; Camptothecin; Cyclosporine; Cyclosporins; Fluorouracil; Irinotecan; Panitumumab

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal adenocarcinoma meeting 1 of the following criteria:

• Previous or current histologically confirmed primary adenocarcinoma of the colon or rectum and clinical/radiological evidence of advanced or metastatic disease

• Histologically or cytologically confirmed metastatic adenocarcinoma with clinical or radiological evidence of colorectal primary tumor

• Unidimensionally measurable disease

• Disease progression during or after prior fluorouracil with or without oxaliplatin therapy and/or with or without bevacizumab

• Adjuvant therapy and/or prior therapy for advanced disease allowed

• No clinical or radiological evidence of pleural effusion or ascites causing ≥ grade 2 dyspnea

• No clinical or radiological evidence of biliary obstruction

• No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy ≥ 12 weeks

• Hemoglobin > 10.0 g/dL

• WBC > 3,000/mm³

• Platelet count > 100,000/mm³

• Glomerular filtration rate > 50 mL/min OR EDTA clearance > 60 mL/min

• Bilirubin < 1.46 mg/dL

• Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• No history of Gilbert's syndrome

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• Capable of completing quality of life questionnaires

• No prior anaphylactic allergic reaction to cetuximab

• No other prior or concurrent cancer (excluding nonmelanomatous skin cancer)

• No unresolved bowel obstruction, uncontrolled gastrointestinal infection, chronic enteropathy (e.g., Crohn's disease or ulcerative colitis), or chronic diarrhea (≥ 4 stools per day) of any cause

• No recent history of seizures

• No clinical or radiological evidence of interstitial pneumonitis or pulmonary fibrosis,

• Capable of reliable oral self-medication

• No other condition that would make the patient unsuitable for participation in this study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No major thoracic or abdominal surgery within the past 4 weeks

• No systemic anticancer therapy within the past 3 weeks

• No prior irinotecan hydrochloride

• No grapefruit juice within 3 days before and after each chemotherapy treatment

• No experimental drug therapy or antibody therapy, other than cetuximab, within the past 6 weeks

• No systemic chemotherapy and/or cetuximab within the past 3 weeks

• No antifungals or antibiotics within the past 5 days

• No ongoing requirement for cyclosporine or any other medication including, but not limited to, the following:

• Ketoconazole, fluconazole, itraconazole

• Erythromycin, clarithromycin, norfloxacin

• Diltiazem hydrochloride, verapamil, amiodarone hydrochloride

• Fluvoxamine