Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005981
  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 II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: O(6)-Benzylguanine Carmustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
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
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Smitha Krishnamurthi, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067969, CWRU-1298, NCI-89
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005981     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Carmustine
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Colorectal Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Carmustine
Enzyme Inhibitors
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009