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Phase II Trial Of CQS (NSC 339004) In Platinum-Refractory Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial Of CQS (NSC 339004) In Platinum-Refractory Small Cell Lung Cancer


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Primo N. Lara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

00104

NCT ID:

NCT00008372

Start Date:

December 2000

Completion Date:

September 2002

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817