Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT01258127
Status:
UNKNOWN
Last Update Posted:
2010-12-10
First Post:
2010-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pemetrexed/Carboplatin vs Vinorelbine/Carboplatin in Patients With Completely Resected Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Shanghai Nancy Medical Sci-Tech Co. Ltd
Organization:
Study Overview
Official Title:
Adjuvant Chemotherapy of Pemetrexed/Carboplatin Compared With Vinorelbine/Carboplatin in Patients With Completely Resected NSCLC
Status:
UNKNOWN
Status Verified Date:
2010-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this randomized phase II trial is to evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely resected non-small cell lung cancer (NSCLC).
Detailed Description:
Pemetrexed, a multi-target folate antimetabolite, shows clear activity in non-small cell lung cancer (NSCLC). In a phase III study for patients with previously treated advanced NSCLC, the efficacy of single-agent pemetrexed, as determined by overall survival, was similar to that of docetaxel. (Hanna et al, 2004) The combination of carboplatin and pemetrexed has been of particular interest because it has demonstrated both good efficacy and a tolerable side effect profile. Phase I studies evaluated pemetrexed plus carboplatin in patients with malignant pleural mesothelioma, showed the regimen was efficacious and well tolerated. (Hughes et al, 2002) The combination of oxaliplatin and pemetrexed was compared with carboplatin and pemetrexed as first-line therapy for advanced NSCLC in a randomized phase II study. Response rates were 27 and 33%, respectively, and not statistically different. Toxicity in the carboplatin/pemetrexed arm was low, this doublet can be delivered easily and is well tolerated. Dose reductions occur only in 3.7% cycles. (Scagliotti et al, 2005) Therefore, it seems reasonable to test a less toxic regimen in patients with NSCLC after complete (R0) resection of the tumor, where reduced toxicities might improve the feasibility of drug delivery, compliance and the convenience of treatment for the patient and hence perhaps improve survival. The main purpose of this randomized phase II trial is to evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely resected NSCLC.
Study Oversight
Has Oversight DMC:
True
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?: