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A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Study Comparing Etoposide and Cisplatin With Etoposide, Cisplatin and Paclitaxel in Patients With Extensive Small Cell Lung Cancer

OBJECTIVES: I. Determine whether the addition of paclitaxel to standard chemotherapy
treatment comprising etoposide and cisplatin improves the survival of patients with
extensive stage small cell lung cancer. II. Compare the tumor response rate and failure-free
survival of these patients treated with these regimens. III. Describe and compare the toxic
effects associated with these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to performance status
and gender. Patients are randomized to one of two treatment arms. Arm I: Patients receive
cisplatin IV on day 1 and etoposide IV over 1 hour on days 1-3. Arm II: Patients receive
paclitaxel IV over 3 hours on day 1 and cisplatin and etoposide as in arm I. Patients then
receive filgrastim (G-CSF) subcutaneously on days 4-18. Treatment repeats in both arms every
21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at least every 2 months for 2 years, every 4 months for 1 year, and
then at least every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 670 patients (335 per arm) will be accrued for this study
within 16 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically documented extensive stage small
cell carcinoma of the bronchus Measurable or evaluable disease No pleural effusions, bone
scan abnormalities, or bone marrow biopsies as only evidence of disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-1 Hematopoietic:
Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin less than 1.5 mg/dL SGOT less than 2 times normal Renal: Serum creatinine no
greater than 1.5 mg/dL Cardiovascular: No cardiac disease Pulmonary: No interstitial
pneumonia No fibroid lung Other: Not pregnant or nursing Fertile patients must use
effective contraception No psychiatric illness No malabsorption disorder No uncontrolled
infection No uncontrolled diabetes mellitus No prior or concurrent malignancy within the
past 5 years except carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine
therapy: No chronic steroid therapy (except steroids for adrenal failure or hormones for
non-disease related conditions) Radiotherapy: No prior pelvic or mediastinal radiotherapy
Surgery: Not specified Other: No concurrent anticonvulsants

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Harvey B. Niell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Memphis


United States: Food and Drug Administration

Study ID:




Start Date:

April 1998

Completion Date:

January 2006

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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