Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005864
First received: June 2, 2000
Last updated: January 30, 2013
Last verified: September 2002
  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 2

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

Resource links provided by NLM:


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

Study Start Date: April 2000
Study Completion Date: February 2004
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
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: 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
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Study Chair: Eric H. Kraut, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005864     History of Changes
Other Study ID Numbers: CDR0000067896, OSU-NCI-56, NCI-56
Study First Received: June 2, 2000
Last Updated: January 30, 2013
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

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
Sulfanilamide
Sulfanilamides
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 31, 2014