Back to resultsCombination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
filgrastim
carboplatin
etoposide
ifosfamide
in vitro-treated peripheral blood stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer
Eligibility 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
Sites / Locations
- CHR de Besancon - Hopital Saint-Jacques
- Institut Bergonie
- CMC Bligny
- Centre de Lute Contre le Cancer,Georges-Francois Leclerc
- CHR de Grenoble - La Tronche
- Centre Leon Berard
- Hopital Louis Pradel
- Institut J. Paoli and I. Calmettes
- Hopital Arnaud de Villeneuve
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Centre Antoine Lacassagne
- Institut Curie - Section Medicale
- Hopital Saint Antoine
- Hopital Tenon
- Hopital Jules Courmont - Centre Hospitalier Lyon Sud
- Hopital Rene Dubos
- Institut Jean Godinot
- Centre Rene Huguenin
- Hopitaux Universitaire de Strasbourg
- Institut Claudius Regaud
- CHRU de Nancy - Hopitaux de Brabois
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003860
Brief Title
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer
Official Title
Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1998 (Actual)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated peripheral blood stem cell transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique N. Trillet-Lenoir, MD
Organizational Affiliation
Centre Hospitalier Lyon Sud
Official's Role
Study Chair
Facility Information:
Facility Name
CHR de Besancon - Hopital Saint-Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CMC Bligny
City
Briis Sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Louis Pradel
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Rene Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Hopitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
CHRU de Nancy - Hopitaux de Brabois
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
12. IPD Sharing Statement
Learn more about this trial
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer
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