Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389688
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2006-10-18
Brief Title:
Pemetrexed Disodium and Cisplatin Before or After Surgery in Treating Patients With Stage IB or Stage II Non-Small Cell Lung Cancer That Can be Removed by Surgery
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as pemetrexed disodium and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet known whether combination chemotherapy is more effective before or after surgery in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery
PURPOSE This randomized phase II trial is studying the side effects of pemetrexed disodium and cisplatin and comparing how well they work when given before or after surgery in treating patients with stage IB or stage II non-small cell lung cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the tolerability in terms of drug delivery and toxicity of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectable stage IB or II non-small cell lung cancer
Secondary
Determine the overall toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the overall clinical response rate pathologic complete response and resectability rate in patients treated with neoadjuvant chemotherapy
Determine the surgical morbidity and mortality of patients treated with these regimens
Determine the fraction of patients in the adjuvant arm that receives chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to institution histological subtype squamous vs nonsquamous and clinical stage IB vs II Patients are randomized to 1 of 2 treatment arms
Arm I neoadjuvant chemotherapy Patients receive cisplatin IV over 3-6 hours and pemetrexed disodium IV on day 1 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity Four to six weeks after completion of chemotherapy patients undergo surgery
Arm II adjuvant chemotherapy Patients undergo surgery Beginning 4-8 weeks after surgery patients receive cisplatin and pemetrexed disodium as in arm I
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 132 patients will be accrued for this study
Primary
Compare the tolerability in terms of drug delivery and toxicity of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectable stage IB or II non-small cell lung cancer
Secondary
Determine the overall toxicity of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
Determine the overall clinical response rate pathologic complete response and resectability rate in patients treated with neoadjuvant chemotherapy
Determine the surgical morbidity and mortality of patients treated with these regimens
Determine the fraction of patients in the adjuvant arm that receives chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to institution histological subtype squamous vs nonsquamous and clinical stage IB vs II Patients are randomized to 1 of 2 treatment arms
Arm I neoadjuvant chemotherapy Patients receive cisplatin IV over 3-6 hours and pemetrexed disodium IV on day 1 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity Four to six weeks after completion of chemotherapy patients undergo surgery
Arm II adjuvant chemotherapy Patients undergo surgery Beginning 4-8 weeks after surgery patients receive cisplatin and pemetrexed disodium as in arm I
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 132 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-08051 | None | None | None |
| 2005-003822-25 | EUDRACT_NUMBER | None | None |