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

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ClinicalTrials.gov Identifier: NCT00003860
Recruitment Status : Unknown
Verified December 1999 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 16, 2004
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: ifosfamide Procedure: in vitro-treated peripheral blood stem cell transplantation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer
Study Start Date : September 1998

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003860


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Veronique N. Trillet-Lenoir, MD Centre Hospitalier Lyon Sud
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ClinicalTrials.gov Identifier: NCT00003860    
Other Study ID Numbers: CDR0000067023
FRE-FNCLCC-98003-CLEO
EU-98072
FRE-FNCLCC-CLEOPATRE03
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: December 1999
Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents