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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
O6-benzylguanine
carmustine
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005981
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
O6-benzylguanine
Intervention Description
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
Intervention Name(s)
carmustine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
Time Frame
Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smitha Krishnamurthi, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

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