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Home > "C" Clinical Trials Conditions > Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer

Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer



Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer

For Condition: recurrent rectal cancer,stage 4 colon cancer,recurrent colon cancer,Stage 4 rectal cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: 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.
Details: OBJECTIVES: I. Assess the antitumor activity and toxicities of chloroquinoxaline sulfonamide in patients with stage IV colorectal cancer. PROTOCOL 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EricKraut,  Study Chair,  Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0752
United States
 

Central Baptist Hospital
Lexington,  Kentucky,  40503
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067896;  NCI-56,OSU-NCI-56
Study Start Date: April 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005864

Other Stage 4 Colon Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer

2. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

3. Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer

4. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer

5. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy

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