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A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

Phase 2/Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II/III Double Blind Randomized Trial of BMS-275291 vs. Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-small Cell Lung Cancer


- Compare the overall survival of patients with advanced or metastatic non-small cell
lung cancer treated with paclitaxel and carboplatin with or without BMS-275291.

- Compare the incidence of grade 2 or higher drug related arthritis, arthralgia and/or
myalgia in patients treated with these regimens. (Phase II only)

- Compare the objective tumor response rate, time to response, and response duration in
patients treated with these regimens.

- Compare the nature, severity, and frequency of toxic effects of these regimens in these

- Compare the progression free survival of patients treated with these regimens. (Phase
III only)

- Correlate the expression of serum/plasma and tissue matrix metalloproteinases (MMP)
levels and other markers with outcomes and response in patients treated with these

- Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
are stratified according to center, disease stage (IIIB vs IV), and ECOG performance status
(0-1 vs 2). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1 plus oral BMS-275291 daily on days 1-21.

- Arm II: Patients receive paclitaxel and carboplatin as in arm I plus oral placebo daily
on days 1-21.

Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. BMS-275291 or placebo continues beyond 8 courses in the absence of
disease progression.

Quality of life is assessed.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 776 patients will be accrued for this study within 27 months.

Inclusion Criteria


- Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer

- Local or metastatic failure after surgery and/or radiotherapy allowed

- Phase II only:

- At least one measurable lesion

- At least 20 mm by conventional techniques OR 10 mm by spiral CT scan

- No known CNS metastases unless asymptomatic and at least 4 weeks since prior
corticosteroid therapy



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2 times ULN (5 times ULN for liver metastases)


- Creatinine no greater than 1.5 times ULN


- No significant cardiac disease

- No uncontrolled high blood pressure, unstable angina, congestive heart failure,
second or third degree atrioventricular conduction defects, or ventricular
arrhythmias requiring medication

- No myocardial infarction within the past year


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reaction to drugs containing Cremophor EL

- No serious active infection or other underlying medical condition that would preclude
study participation

- No peripheral neuropathy

- No condition (e.g., psychological, geographical) that would preclude study

- No prior breast cancer or melanoma

- No other prior malignancy within the past 5 years except carcinoma in situ, basal
cell or squamous cell skin cancer, or other cancer that has been curatively treated


Biologic therapy:

- No prior immunotherapy

- No prior biological response modifiers

- No other concurrent biologic therapy or immunotherapy


- No prior antineoplastic chemotherapy, including intrapleural chemotherapy

Endocrine therapy:

- See Disease Characteristics


- See Disease Characteristics

- No prior radiotherapy to study lesion (unless evidence of disease progression) or to
30% or greater of marrow bearing bones

- At least 1 week since prior radiotherapy and recovered

- No concurrent radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior major surgery

- No concurrent surgery


- At least 2 weeks since prior investigational drugs

- No other concurrent cytotoxic anticancer therapy

- No other investigational drugs during and for 30 days after study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Principal Investigator

Michael Smylie, MD, MB, ChB

Investigator Role:

Study Chair

Investigator Affiliation:

Cross Cancer Institute at University of Alberta


Canada: Health Canada

Study ID:




Start Date:

April 2000

Completion Date:

February 2009

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Baptist Regional Cancer Center - Knoxville Knoxville, Tennessee  37901
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Jackson-Madison County General Hospital Jackson, Tennessee  38301
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Scripps Clinic La Jolla, California  92037
Lahey Clinic - Burlington Burlington, Massachusetts  01805
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Creighton University Cancer Center Omaha, Nebraska  68131-2197
Carle Cancer Center Urbana, Illinois  61801
Saint Thomas Hospital Nashville, Tennessee  37205
Queen's Medical Center Honolulu, Hawaii  96813
Erlanger Health Systems Chattanooga, Tennessee  37403
Williamson Medical Center Franklin, Tennessee  37067
Central Georgia Hematology Oncology, P.C. Macon, Georgia  31201
Duke University Medical Center Durham, North Carolina  27710
Memorial Hospital Cancer Center - Chattanooga Chattanooga, Tennessee  37404
Meharry Medical College Nashville, Tennessee  37208-3599
Division of Medical Oncology - Vanderbilt Nashville, Tennessee  37232-5536