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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014