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A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients


- 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


- 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

- Bidimensionally measurable or evaluable disease

- Brain metastases allowed provided clinically stable after treatment with surgery
and/or radiotherapy



- 18 and over

Performance status:

- ECOG 2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 5 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min


- 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


- 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


Biologic therapy:

- Not specified


- No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

- Not specified


- 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


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




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



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