Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
Irinotecan or Fluorouracil Plus Leucovorin in Treating Patients With Previously Treated Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Giving the drugs in different combinations may kill more tumor
 cells.

 PURPOSE: Phase II trial to compare the effectiveness of either irinotecan or fluorouracil
 plus leucovorin in treating patients who have metastatic colorectal cancer that has been
 previously treated with oxaliplatin with or without irinotecan.
OBJECTIVES:

 -  Determine the tumor response rate in patients receiving irinotecan or fluorouracil and
 leucovorin calcium for metastatic colorectal cancer previously treated with oxaliplatin
 with or without irinotecan.

 -  Determine the time to tumor progression, time to treatment failure, and overall survival
 of patients treated with these regimens.

 -  Determine the toxic effects of these regimens in these patients.

 -  Evaluate the quality of life of patients treated with these regimens.

 OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy
 (oxaliplatin-based therapy vs irinotecan and oxaliplatin combination therapy). Patients are
 assigned to one of two treatment groups.

 -  Group I (prior oxaliplatin-based chemotherapy): Patients receive irinotecan IV over 90
 minutes on day 1. Treatment repeats every 3 weeks.

 -  Group II (prior irinotecan and oxaliplatin combination chemotherapy): Patients receive
 leucovorin calcium IV over 2 hours and fluorouracil IV continuously on days 1 and 2.
 Treatment repeats every 2 weeks.

 -  Both groups: Treatment continues in the absence of disease progression or unacceptable
 toxicity. Patients with a confirmed complete response for 2 consecutive courses may
 discontinue treatment at investigator's discretion.

 Quality of life is assessed at baseline, approximately every 6 weeks during treatment, and
 then after the last course of treatment.

 Patients are followed every 3 months for 5 years.
DISEASE CHARACTERISTICS:

 -  Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable
 to radiotherapy with curative intent

 -  Progressive disease after one of the following prior treatments for metastatic
 disease:

 -  Oxaliplatin-based chemotherapy

 -  Irinotecan and oxaliplatin combination chemotherapy

 -  At least 1 measurable lesion

 -  At least 20 mm in at least one dimension

 -  No known CNS metastases or carcinomatous meningitis

 PATIENT CHARACTERISTICS:

 Age:

 -  18 and over

 Performance status:

 -  ECOG 0-2

 Life expectancy:

 -  At least 12 weeks

 Hematopoietic:

 -  Absolute neutrophil count at least 2,000/mm^3

 -  Platelet count at least 100,000/mm^3

 Hepatic:

 -  Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN)

 -  AST no greater than 5 times ULN

 Renal:

 -  Creatinine no greater than 1.5 times ULN

 Cardiovascular:

 -  No unstable angina

 -  No symptomatic congestive heart failure

 -  No serious uncontrolled cardiac arrhythmia

 Other:

 -  No active or uncontrolled infection

 -  No evidence of other serious illness

 -  No other malignancy within the past 5 years except adequately treated basal cell or
 squamous cell skin cancer or noninvasive carcinomas

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  No concurrent sargramostim (GM-CSF)

 Chemotherapy:

 -  See Disease Characteristics

 -  At least 4 weeks since prior chemotherapy

 -  No more than 1 prior chemotherapy regimen for advanced colorectal cancer

 -  Prior adjuvant chemotherapy allowed

 Endocrine therapy:

 -  Not specified

 Radiotherapy:

 -  See Disease Characteristics

 -  No prior radiotherapy to more than 25% of bone marrow

 Surgery:

 -  See Disease Characteristics

 -  At least 4 weeks since prior major surgery