Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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.]
Eligibility Criteria
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
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Platelet count at least 100,000/mm^3
-
Hemoglobin greater than 8 g/dL
Hepatic:
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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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Smitha Krishnamurthi, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CWRU1298
- U01CA063200
- P30CA043703
- CWRU-1298
- NCI-89