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Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer

Phase 3
18 Years
75 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer

OBJECTIVES: I. Compare the overall survival and survival without recurrence of patients with
extensive stage small cell lung cancer after receiving cisplatin and etoposide with or
without epirubicin and cyclophosphamide. II. Compare the relative dose and intensity of
cisplatin and etoposide between the two groups of patients. III. Compare the complete and
objective response rate and quality of life of these patients. IV. Compare the toxic effects
of these 2 regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day
2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1
and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days
for up to 6 courses. Patients who achieve a partial or complete response receive cerebral
and/or thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3
of every 4 weeks. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven extensive stage small cell lung cancer
Extends beyond hemithorax and supraclavicular lymph nodes Pleural effusions allowed
Bidimensionally measurable disease Bone marrow metastases allowed No symptomatic CNS
metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-2 Life expectancy: Not
specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine less
than 1.24 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiac
insufficiency No uncontrolled cardiac disease LVEF greater than 50% OR ECHO greater than
30% Other: Not pregnant Fertile patients must use effective contraception No psychoses No
active infection No loss of weight greater than 10% during the last 3 months No other
malignancy except nonmelanomatous skin cancer or stage I cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy
Chemotherapy: No prior or other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior or concurrent radiotherapy Surgery: No prior or concurrent surgery

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jean Louis Pujol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Arnaud de Villeneuve


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

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