Lung CancerPhase 3NCT00011921
Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer
A Phase 3 study testing filgrastim, carboplatin and epirubicin hydrochloride in people with Lung Cancer, run by EBMT Solid Tumors Working Party at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- filgrastim, carboplatin and epirubicin hydrochloride
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 1997to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer
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.
Read the 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
- Being tested
- filgrastim, carboplatin, epirubicin hydrochloride, etoposide, etoposide phosphate
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carboplatinDrug
epirubicin hydrochlorideDrug
etoposideDrug
etoposide phosphateDrug
ifosfamideDrug
paclitaxelDrug
autologous bone marrow transplantationProcedure or surgery
bone marrow ablation with stem cell supportProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) at 3 years
Secondary outcomes (3)
Progression-free survival (PFS) at 3 years
Toxicity at 3 years
Quality of life (QOL) at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EBMT Solid Tumors Working Party
- Sponsor type
- University, hospital or other
- Investigators
- Serge Leyvraz, MD, Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011921
- Sponsor's protocol ID
- CDR0000068379
- Other IDs
- EBMT-RANDOM-ICE, EU-98001, NCI-V01-1645
- Status last verified
- Mar 2003
- First submitted
- 3 Mar 2001
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00011921
- Acronym / sponsor ID
- CDR0000068379
- Conditions
- Lung Cancer
- Keywords
- limited stage small cell lung cancer, extensive stage small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- EBMT Solid Tumors Working PartyUniversity, hospital or other
- Study start
- Sep 1997
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| epirubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| etoposide phosphate | Drug | – |
| ifosfamide | Drug | – |
| paclitaxel | Drug | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Overall survival (OS) at 3 years
3 secondary outcomes
Progression-free survival (PFS) at 3 years
Toxicity at 3 years
Quality of life (QOL) at 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge Leyvraz, MD study chair
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing filgrastim, carboplatin and epirubicin hydrochloride in people with Lung Cancer, run by EBMT Solid Tumors Working Party at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) at 3 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.