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

NCT ID: NCT00003860

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30
• Study Completion Date: 2005-09-30

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.

Detailed Description

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

in vitro-treated peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronique N. Trillet-Lenoir, MD

Role: STUDY_CHAIR

Centre Hospitalier Lyon Sud

Locations

CHR de Besancon - Hopital Saint-Jacques

Besançon, , France

Institut Bergonie

Bordeaux, , France

CMC Bligny

Briis-sous-Forges, , France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc

Dijon, , France

CHR de Grenoble - La Tronche

Grenoble, , France

Centre Leon Berard

Lyon, , France

Hopital Louis Pradel

Lyon, , France

Institut J. Paoli and I. Calmettes

Marseille, , France

Hopital Arnaud de Villeneuve

Montpellier, , France

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

Montpellier, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie - Section Medicale

Paris, , France

Hopital Saint Antoine

Paris, , France

Hopital Tenon

Paris, , France

Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Hopital Rene Dubos

Pontoise, , France

Institut Jean Godinot

Reims, , France

Centre Rene Huguenin

Saint-Cloud, , France

Hopitaux Universitaire de Strasbourg

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

CHRU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

FRE-FNCLCC-98003-CLEO

Identifier Type: -

Identifier Source: secondary_id

EU-98072

Identifier Type: -

Identifier Source: secondary_id

FRE-FNCLCC-CLEOPATRE03

Identifier Type: -

Identifier Source: secondary_id

CDR0000067023

Identifier Type: -

Identifier Source: org_study_id