Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer

NCT00003860 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000067023FRE-FNCLCC-98003-CLEOEU-98072FRE-FNCLCC-CLEOPATRE03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

etoposide DRUG

ifosfamide DRUG

in vitro-treated peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (22)

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CMC Bligny

Briis-sous-Forges, 91640, France

Location

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, 21079, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Louis Pradel

Lyon, 69394, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Filgrastim; Carboplatin; Etoposide; Ifosfamide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Veronique N. Trillet-Lenoir, MD

  Centre Hospitalier Lyon Sud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: June 16, 2004
• Study Start: September 1, 1998
• Primary Completion: August 1, 2000
• Study Completion: September 1, 2005
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

FR (22)