Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00005981
First received: July 5, 2000
Last updated: June 9, 2010
Last verified: June 2010
  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:


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:
    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.
    Drug: 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.
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
Investigators
Study Chair: Smitha Krishnamurthi, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
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 April 17, 2014