A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
18 Years
N/A
Both
Lung Cancer
Trial Information
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
OBJECTIVES:
- Compare overall survival, response rate, and time to progression of patients with
non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine
and cisplatin.
- Compare the toxicities of each of these 2 regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB
with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients
are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over
15-30 minutes on day 1.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by
cisplatin IV over 1 hour on day 1 only.
Treatment continues in both arms every 21 days for up to 6 courses in the absence of
unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this
study within 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung carcinoma of any of the
following subtypes:
- Squamous cell
- Adenocarcinoma
- Large cell anaplastic
- Bronchioalveolar
- Non-small cell carcinoma not otherwise specified
- No small cell anaplastic elements allowed
- Must have:
- Recurrent disease after prior radiotherapy or surgery OR
- Stage IV disease with distant metastases OR
- Stage IIIB disease presenting with pleural or pericardial effusion on CT or
chest x-ray or pleural implants documented pathologically or on CT or chest
x-ray
- Bidimensionally measurable or evaluable disease
- Brain metastases allowed provided clinically stable after treatment with surgery
and/or radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 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 uncontrolled high blood pressure, unstable angina, or congestive heart failure
- No myocardial infarction within the past 6 months
- No serious ventricular arrhythmias requiring medication
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other active malignancies requiring ongoing treatment
- No uncontrolled serious active infections
- No suspected hypersensitivity to agents that utilize Cremophor
- No evidence of neuropathy grade 2 or greater by history or physical examination
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for non-small cell lung cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to only site of measurable or evaluable disease unless
subsequent progression documented by physical exam, radiograph, or pathology
- Recovered from prior radiotherapy
- No concurrent radiotherapy except for whole brain radiation for developing brain
metastases
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Corey J. Langer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068012
NCT ID:
NCT00006004
Start Date:
May 2000
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- adenosquamous cell lung cancer
- bronchoalveolar cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| James P. Wilmot Cancer Center | Rochester, New York 14642 |
| Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| Mercy Medical Center | Des Moines, Iowa 50314 |
| Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Alegent Health-Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
