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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00003860
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-08
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Study Completion: 2005-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (22)

Hopitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

CHRU de Nancy - Hopitaux de Brabois; 🇫🇷 Vandoeuvre-Les-Nancy, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CHR de Besancon - Hopital Saint-Jacques; 🇫🇷 Besancon, France

Centre de Lute Contre le Cancer,Georges-Francois Leclerc; 🇫🇷 Dijon, France

CHR de Grenoble - La Tronche; 🇫🇷 Grenoble, France

Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Hopital Louis Pradel; 🇫🇷 Lyon, France

Hopital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hopital Rene Dubos; 🇫🇷 Pontoise, France

Institut Jean Godinot; 🇫🇷 Reims, France

Institut Curie - Section Medicale; 🇫🇷 Paris, France

CMC Bligny; 🇫🇷 Briis Sous Forges, France

Hopital Jules Courmont - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Centre Leon Berard; 🇫🇷 Lyon, France

Hopital Tenon; 🇫🇷 Paris, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France