Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer

NCT ID: NCT00011921

Last Updated: 2013-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-09-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer.

Detailed Description

OBJECTIVES:

• Compare the overall survival of patients with limited or extensive stage small cell lung cancer treated with sequential high-dose ifosfamide, carboplatin, and etoposide phosphate followed by autologous peripheral blood stem cell or bone marrow transplantation versus standard ifosfamide, carboplatin, and etoposide.
• Compare the progression-free survival, time to treatment failure, and response rate in patients treated with these regimens.
• Compare the toxic effects of these regimens in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (limited disease vs extensive disease with vs without liver metastases), performance status (0 vs 1), gender, LDH level (normal vs abnormal), and participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive induction therapy comprising epirubicin IV over 4 hours on day 1 and paclitaxel IV over 3 hours on day 2. Treatment repeats every 21 days for a total of 2 courses. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 and continuing for 10 days or during course 2 until peripheral blood stem cell (PBSC) collection is completed. After completion of induction chemotherapy, autologous PBSCs or bone marrow is collected.

Within 28 days of the start of the second course of induction chemotherapy, patients receive high-dose ifosfamide IV over 17 hours, carboplatin IV over 3 hours, and etoposide phosphate IV over 3 hours on days 1-4. At 48 hours after completion of high-dose chemotherapy, patients undergo autologous PBSC or bone marrow transplantation and then receive G-CSF SC for 14 days. Treatment repeats every 28 days for 3 courses.

• Arm II: Patients receive ifosfamide IV continuously over 24 hours, carboplatin IV over 1 hour on day 1, and etoposide IV over 45 minutes on days 1 and 2. Treatment repeats every 28 days for 6 courses.

After completion of high-dose or standard chemotherapy, patients with limited disease or extensive disease in complete remission receive thoracic radiotherapy daily on days 1-5 for 6 weeks. All patients in complete remission receive prophylactic cranial radiotherapy daily on days 1-5 for 3 weeks.

Quality of life is assessed at baseline, at the beginning of courses 1 and 3 (high-dose chemotherapy) or courses 3 and 5 (standard chemotherapy), and then at 7, 12, and 18 months.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 430 patients (215 per treatment arm) will be accrued for this study within 3 years.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer; extensive stage small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

epirubicin hydrochloride

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

etoposide phosphate

Intervention Type: DRUG

ifosfamide

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

autologous bone marrow transplantation

Intervention Type: PROCEDURE

bone marrow ablation with stem cell support

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer

• Limited disease or extensive disease with no more than 2 metastatic sites
• No CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 65 and under

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3 OR
• Platelet count greater than 100,000/mm^3 OR
• Hemoglobin at least 10.0 g/dL

Hepatic:

• AST/ALT less than 2.5 times upper limit of normal (ULN)
• Alkaline phosphatase less than 2.5 times ULN
• Bilirubin less than 2.5 times ULN

Renal:

• Creatinine clearance at least 60 mL/min
• No renal function that would preclude chemotherapy

Cardiovascular:

• No congestive heart failure
• LVEF at least 50%
• No cardiac function that would preclude chemotherapy

Other:

• No other malignancy within the past 3 years except for basal cell skin cancer or carcinoma in situ of the cervix
• No psychiatric disorder or any other disorder that would preclude study participation
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EBMT Solid Tumors Working Party

OTHER

Sponsor Role: lead

Principal Investigators

Serge Leyvraz, MD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

EBMT-RANDOM-ICE

Identifier Type: -

Identifier Source: secondary_id

EU-98001

Identifier Type: -

Identifier Source: secondary_id

NCI-V01-1645

Identifier Type: -

Identifier Source: secondary_id

CDR0000068379

Identifier Type: -

Identifier Source: org_study_id