Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

NCT ID: NCT00005981

Last Updated: 2010-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2003-11-30

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

O6-benzylguanine

Patients receive O6-benzylguanine (BG) IV over 1 hour. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

carmustine

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Cancer Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Smitha Krishnamurthi, MD

Role: STUDY_CHAIR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

U01CA063200

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-1298

Identifier Type: -

Identifier Source: secondary_id

NCI-89

Identifier Type: -

Identifier Source: secondary_id

CWRU1298

Identifier Type: -

Identifier Source: org_study_id