Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00005981


Primary Contact:

Study Chair
Smitha Krishnamurthi, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2017

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