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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.
Detailed description
OBJECTIVES: * Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine. * Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen. * Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.
Interventions
DRUGO6-benzylguanine
Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
DRUGcarmustine
Carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal carcinoma * Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 4,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Bilirubin no greater than 1.2 mg/dL * AST and ALT less than 2.5 times upper limit of normal (ULN) * PT no greater than ULN (not on anticoagulation therapy) Renal: * Creatinine no greater than 1.5 mg/dL * Creatine clearance greater than 60 mL/min Pulmonary: * DLCO at least 60% Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study * No other concurrent active malignancies * Prior malignancies presumed to be cured allowed * No other concurrent uncontrolled severe medical problem that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 months since prior adjuvant chemotherapy without disease recurrence * No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy: * Not specified Radiotherapy: * Prior adjuvant radiotherapy allowed * No prior radiotherapy to more than 25% of total bone marrow Surgery: * Not specified Other: * No other prior therapy for advanced disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine. | Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. |
Countries
United States
Outcome results
None listed