Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: O6-benzylguanine Drug: carmustine	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Carmustine

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	June 2000
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005981

Locations

United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Smitha Krishnamurthi, MD

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Smitha Krishnamurthi, MD, Ireland Cancer Center at University Hospitals Cancer Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00005981 History of Changes
Other Study ID Numbers:	CWRU1298, U01CA063200, P30CA043703, CWRU-1298, NCI-89
Study First Received:	July 5, 2000
Last Updated:	June 9, 2010
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:

stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Carmustine
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013