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A Randomized Phase II Trial of Two Different Schedules of Administration of Rebeccamycin Analog in Patients With Advanced Non-Small Cell Lung Cancer


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

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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 HospitalDetroit, Michigan  48202
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065