Clinical trial NCT00005981: Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Official title: Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
timeFrame: Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Smitha Krishnamurthi, MD
role: STUDY_CHAIR
References: