sarcnu in treating patients with recurrent or metastatic colorectal cancer

Conditions: Colorectal Cancer

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.

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.

Eligibility 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

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer