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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003860
• Other study ID #: CDR0000067023
• Secondary ID: FRE-FNCLCC-98003
• Status: Completed
• Phase: Phase 2
• Start date: September 1998
• Est. completion date: September 2005

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2005
• Est. primary completion date: August 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• etoposide

• ifosfamide

Procedure:
• in vitro-treated peripheral blood stem cell transplantation

Locations

Country	Name	City	State
France	CHR de Besancon - Hopital Saint-Jacques	Besancon
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	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital Arnaud de Villeneuve	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Institut Curie - Section Medicale	Paris
France	Hopital Jules Courmont - Centre Hospitalier Lyon Sud	Pierre Benite
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	Vandoeuvre-Les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France,