Two Rebeccamycin Analogue Regimens in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Case Comprehensive Cancer Center42 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of rebeccamycin analogue is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two rebeccamycin analogue regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES: * Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue via 1 infusion vs 5 daily infusions every 3 weeks. * Compare the response duration in patients treated with these regimens. * Compare the toxicity profiles of these two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 or 1 vs 2) and participating center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. * Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 36-64 patients (18-32 per arm) will be accrued for this study at a rate of 3-4 patients per month.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

becatecarinDRUG

Arm I: Patients receive rebeccamycin analogue IV over 1 hour on day 1. Arm II: Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment for both arms repeats every 3 weeks for 6-8 courses in the absence of disease progression or unacceptable toxicity.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven stage IIIB (with pleural effusions), IV, or recurrent non-small cell lung cancer with failure on 1 prior chemotherapy regimen * Measurable disease PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT less than 2 times normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No more than 1 prior chemotherapy regimen * At least 4 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent combination antiretroviral therapy for HIV

Locations (2)

Henry Ford Hospital

Detroit, Michigan, United States

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue

Time frame: via 1 infusion vs 5 daily infusions every 3 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.