RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer.

Condition	Treatment or Intervention	Phase
extensive stage small cell lung cancer	Drug: carboplatin  Drug: etoposide  Drug: filgrastim  Drug: ifosfamide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   60 Years

Criteria

PROTOCOL ENTRY 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 corticosteroids

--Prior/Concurrent Therapy--

• See Disease Characteristics; No prior antineoplastic therapy

--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

France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France
      Centre Rene Huguenin, Saint Cloud,  92210,  France
      CHR de Besancon - Hopital Saint-Jacques, Besancon,  25030,  France
      CHR de Grenoble - La Tronche, Grenoble,  38043,  France
      CHRU de Nancy - Hopitaux de Brabois, Vandoeuvre-les-Nancy,  54511,  France
      CMC Bligny, Briis-sous-Forges,  91640,  France
      Hopital Arnaud de Villeneuve, Montpellier,  34295,  France
      Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre-Benite,  69495,  France
      Hopital Louis Pradel, Lyon,  69394,  France
      Hopital Rene Dubos, Pontoise,  95300,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Tenon, Paris,  75970,  France
      Hopitaux Universitaire de Strasbourg, Strasbourg,  67091,  France
      Institut Bergonie, Bordeaux,  33076,  France
      Institut Claudius Regaud, Toulouse,  31052,  France
      Institut Curie - Section Medicale, Paris,  75248,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France
      Institut Jean Godinot, Reims,  51056,  France

Study chairs or principal investigators

Veronique N. Trillet-Lenoir,  Study Chair,  Federation Nationale des Centres de Lutte Contre le Cancer   

Study ID Numbers:  CDR0000067023; FRE-FNCLCC-98003-CLEO; EU-98072; FRE-FNCLCC-CLEOPATRE03
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003860
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08