Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370383
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2006-08-30
Brief Title:
A Study Comparing Sequential Satraplatin Erlotinib to Erlotinib in Unresectable Stage 34 Non-small-cell Lung Cancer NSCLC
Sponsor:
Agennix
Organization:
Agennix
Study Overview
Official Title:
A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
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:
Patients 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer NSCLC frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their inability to tolerate treatment Epidermal growth factor receptor EGFR tyrosine kinase inhibitors TKIs are agents with favorable toxicity profiles that have shown activity in patients with NSCLC Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment However when studied with combination chemotherapy in the first-line setting continuous daily administration of erlotinib did not result in improved patient survival Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination
Satraplatin is an oral investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies Unlike the currently marketed platinum-based drugs satraplatin can be given orally and is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer
The rationale for this study is to develop an active and well-tolerated oral regimen for patients 70 years of age with NSCLC Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle The primary endpoint will be progression-free survival PFS Patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib
Satraplatin is an oral investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies Unlike the currently marketed platinum-based drugs satraplatin can be given orally and is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer
The rationale for this study is to develop an active and well-tolerated oral regimen for patients 70 years of age with NSCLC Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle The primary endpoint will be progression-free survival PFS Patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib
Detailed Description:
Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment However when studied with combination chemotherapy in the first-line setting continuous daily administration of erlotinib did not result in improved patient survival Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination
Satraplatin is an orally administered platinum analogue that has shown promising single-agent activity in multiple tumor types including prostate ovarian and small cell lung cancer Additionally the single-agent activity of satraplatin in NSCLC is similar to that of other commonly used platinum agents used to treat NSCLC However satraplatin is better tolerated than cisplatin causing less renal toxicity and ototoxicity and it can be administered in the outpatient setting From a toxicity profile it is more similar to carboplatin in that myelosuppression is its dose limiting toxicity DLT Satraplatin is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer
The rationale for this study is to develop an active and well-tolerated oral regimen for patients 70 years of age with NSCLC who may not be candidates for aggressive combination systemic chemotherapy Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle As erlotinib has shown an advantage in survival without a commensurate improvement in response rate the primary endpoint will be progression-free survival PFS thus patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib
Satraplatin is an orally administered platinum analogue that has shown promising single-agent activity in multiple tumor types including prostate ovarian and small cell lung cancer Additionally the single-agent activity of satraplatin in NSCLC is similar to that of other commonly used platinum agents used to treat NSCLC However satraplatin is better tolerated than cisplatin causing less renal toxicity and ototoxicity and it can be administered in the outpatient setting From a toxicity profile it is more similar to carboplatin in that myelosuppression is its dose limiting toxicity DLT Satraplatin is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer
The rationale for this study is to develop an active and well-tolerated oral regimen for patients 70 years of age with NSCLC who may not be candidates for aggressive combination systemic chemotherapy Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle As erlotinib has shown an advantage in survival without a commensurate improvement in response rate the primary endpoint will be progression-free survival PFS thus patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib
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