- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00005864
Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer
A Phase II Study of Chloroquinoxaline Sulfonamide (CQS) in Colorectal Cancer Stage IV
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Central Baptist Hospital
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109-0752
- University Of Michigan Comprehensive Cancer Center
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Stati Uniti, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Criteri di partecipazione
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Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
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- Scopo principale: Trattamento
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000067896
- OSU-NCI-56
- NCI-56
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .