Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005981
• Other study ID #: CWRU1298
• Secondary ID: U01CA063200P30CA
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: June 9, 2010
• Start date: June 2000
• Est. completion date: November 2003

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No