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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008372 |
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 small cell lung cancer that has not responded to platinum-based chemotherapy.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: chloroquinoxaline sulfonamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial Of CQS (NSC 339004) In Platinum-Refractory Small Cell Lung Cancer |
Study Start Date: | December 2000 |
OBJECTIVES: I. Determine the efficacy of chloroquinoxaline sulfonamide in patients with platinum-refractory small cell lung cancer. II. Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive chloroquinoxaline sulfonamide IV over 1 hour once a week for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed until death.
PROJECTED ACCRUAL: A total of 12-38 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed platinum-refractory small cell lung cancer No response or progression during or within 6 months of completing platinum based therapy Measurable disease No symptomatic brain or leptomeningeal metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 No hemolytic anemia Hepatic: Bilirubin normal AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiac arrhythmias Other: No other active malignancy requiring concurrent treatment No allergy to sulfonamides Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent corticosteroids to control symptoms of brain and/or leptomeningeal metastases Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy to measurable lesions Surgery: Not specified Other: No concurrent hypoglycemic agents (including insulin)
United States, California | |
Cancer Center and Beckman Research Institute, City of Hope | |
Duarte, California, United States, 91010-3000 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 |
Study Chair: | Primo N. Lara, MD | University of California, Davis |
Study ID Numbers: | CDR0000068401, CHNMC-PHII-26, NCI-57 |
Study First Received: | January 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008372 |
Health Authority: | United States: Federal Government |
extensive stage small cell lung cancer recurrent small cell lung cancer |
Thoracic Neoplasms Carcinoma, Neuroendocrine Recurrence Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Sulfanilamides Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type |
Neoplasms by Site Therapeutic Uses Neoplasms, Nerve Tissue Pharmacologic Actions |