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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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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 CenterCleveland, Ohio  44106-5065