Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
Outcome Time Frame:
Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Safety Issue:
No
Principal Investigator
Smitha Krishnamurthi, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU1298
NCT ID:
NCT00005981
Start Date:
June 2000
Completion Date:
November 2003
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
