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Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer

Phase 2
18 Years
60 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer

OBJECTIVES: I. Determine the feasibility of the administration of intensive chemotherapy
with ifosfamide, carboplatin, and etoposide followed by peripheral blood stem cell support
in patients with small cell lung cancer. II. Determine the rate and duration of response in
these patients after this treatment. III. Determine the progression free and overall
survival of these patients.

OUTLINE: This is an open label, multicenter study. Patients receive 4 courses of intensive
chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day
1 and etoposide IV over 1 hour on days 1 and 2. Filgrastim (G-CSF) is administered
subcutaneously beginning on day 2 and continuing until blood cell counts recover. Courses
repeat every 14 days. Peripheral blood stem cells (PBSC) are collected after course 1. PBSC
are reinfused on day 3 of courses 2 and 3. Patients who experience a complete response
receive prophylactic cerebral irradiation on day 71. Patients are followed every 2 months
for 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven small cell lung cancer Good prognosis on
the Manchester scale, with no more than 2 of the following high risk factors: Karnofsky
less than 60% Hyponatremia (low sodium) Alkaline phosphatase at least 1.5 times upper
limit of normal (ULN) LDH greater than ULN No symptomatic CNS metastases requiring

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: See Disease Characteristics
Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet
count at least 125,000/mm3 Hepatic: See Disease Characteristics Bilirubin less than 1.25
times upper limit of normal (ULN) SGOT/SGPT less than 1.25 times ULN Renal: Creatinine
less than ULN Cardiovascular: LVEF at least 50% No myocardial infarction within 5 years No
uncontrolled cardiac disease Pulmonary: No severe chronic obstructive pulmonary disease
Other: No neurological symptoms greater than grade 2 No severe psychoses No other
concurrent medical problems No active infection HIV negative No allergy to E. coli derived
products No prior malignancy within 5 years except basal cell skin cancer, carcinoma in
situ of the cervix, or lung or respiratory cancer in remission Not pregnant or nursing

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior antineoplastic therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Veronique N. Trillet-Lenoir, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Lyon Sud


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

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