Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; O(6)-benzylguanine

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