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Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer

This study has been completed.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005864
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in treating patients who have stage IV colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: chloroquinoxaline sulfonamide
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   5-Chloroquinoxaline-2-sulfanilamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Chloroquinoxaline Sulfonamide (CQS) in Colorectal Cancer Stage IV

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

Study Start Date:   April 2000

Detailed Description:

OBJECTIVES: I. Assess the antitumor activity and toxicities of chloroquinoxaline sulfonamide in patients with stage IV colorectal cancer.

OUTLINE: This is a multicenter study. Patients receive chloroquinoxaline sulfonamide IV over 1 hour weekly for 4 consecutive weeks. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 30 days.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 8 months.

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

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV colorectal cancer Measurable disease defined as lesions that measure at least 20 mm in one dimension using conventional techniques or at least 10 mm with spiral CT scan not including: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Recurrent disease allowed after adjuvant chemotherapy if recurrence occurred at least 6 months after completion of therapy No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal Cardiovascular: No history of symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia (e.g., supraventricular tachycardia or atrial fibrillation) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant episodes of hypoglycemia in past 6 months No known allergies to compounds of similar chemical or biologic composition to chloroquinoxaline sulfonamide No known glucose-6 phosphate deficiency or hemolytic anemia No uncontrolled concurrent illness (e.g., active infection) No concurrent psychiatric illness or social condition that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: One prior biologic therapy allowed Chemotherapy: See Disease Characteristics No more than one prior chemotherapy for metastatic disease or adjuvant treatment At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: No concurrent oral hypoglycemics or insulin Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No other concurrent investigational agents No concurrent combination antiretroviral treatment for HIV

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005864

Locations
United States, Kentucky
Central Baptist Hospital    
      Lexington, Kentucky, United States, 40503
United States, Michigan
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0752
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University    
      Columbus, Ohio, United States, 43210-1240
Cleveland Clinic Taussig Cancer Center    
      Cleveland, Ohio, United States, 44195

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Eric H. Kraut, MD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
  More Information


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

Study ID Numbers:   CDR0000067896, OSU-NCI-56, NCI-56
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005864
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 Diseases
Digestive System Neoplasms
Sulfanilamides
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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