A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced Non-Small Cell Lung Cancer
N/A
N/A
Both
Lung Cancer
Trial Information
A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compare the efficacy, in terms of response rate, in patients with advanced or recurrent non-small cell lung cancer treated with rebeccamycin analogue
Outcome Time Frame:
via 1 infusion vs 5 daily infusions every 3 weeks.
Safety Issue:
No
Principal Investigator
Afshin Dowlati, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CWRU1599
NCT ID:
NCT00006017
Start Date:
May 2000
Completion Date:
January 2005
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
