Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
Detailed description
OBJECTIVES: * Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer. * Determine the qualitative and quantitative toxicity of this drug in these patients. * Determine the time to progression and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Locally recurrent or metastatic disease * Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 Hepatic: * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary: * DLCO at least 80% predicted * FVC at least 80% predicted * No history of significant pulmonary disease * No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma) Other: * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No other serious illness or medical condition that would preclude study * No ongoing or active uncontrolled infection * No history of significant neurologic or psychiatric disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * Prior adjuvant chemotherapy allowed * No prior nitrosoureas * No prior second-line chemotherapy for recurrent or metastatic disease * At least 4 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Prior radiotherapy as part of primary therapy allowed * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * Prior surgery as part of primary therapy allowed * Prior reoperation for recurrent disease allowed * At least 2 weeks since prior surgery other than biopsy Other: * At least 4 weeks since prior investigational agent * No other concurrent investigational agents or therapy * No other concurrent anticancer therapy
Countries
Canada