Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126581
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2005-08-02
Brief Title:
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Randomized Study of OSI-774 Erlotinib NSC 718781 With or Without CarboplatinPaclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone
Detailed Description:
PRIMARY OBJECTIVES
I To determine the distribution of progression-free survival PFS in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib erlotinib hydrochloride alone arm A or in combination with carboplatinpaclitaxel arm B
SECONDARY OBJECTIVES
I To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
II To determine the frequency of epidermal growth factor receptor EGFR and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog K-ras mutations and anaplastic lymphoma kinase ALK translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers
III To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
IV To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
V To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
VI To estimate the response rate progression-free and overall survival of patients with echinoderm microtubule associated protein like EML4-ALK translocation who received OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-21 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive erlotinib hydrochloride as in Arm I Patients also receive paclitaxel intravenously IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity After completion of 6 cycles of treatment patients may continue to receive erlotinib hydrochloride alone as above
After completion of study treatment patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years
I To determine the distribution of progression-free survival PFS in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib erlotinib hydrochloride alone arm A or in combination with carboplatinpaclitaxel arm B
SECONDARY OBJECTIVES
I To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
II To determine the frequency of epidermal growth factor receptor EGFR and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog K-ras mutations and anaplastic lymphoma kinase ALK translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers
III To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
IV To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
V To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
VI To estimate the response rate progression-free and overall survival of patients with echinoderm microtubule associated protein like EML4-ALK translocation who received OSI-774 erlotinib alone arm A or in combination with carboplatinpaclitaxel arm B
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-21 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive erlotinib hydrochloride as in Arm I Patients also receive paclitaxel intravenously IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1 Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity After completion of 6 cycles of treatment patients may continue to receive erlotinib hydrochloride alone as above
After completion of study treatment patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years
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 |
|---|---|---|---|
| NCI-2009-00464 | REGISTRY | None | None |
| CDR0000437097 | None | None | None |
| CALGB-30406 | OTHER | None | None |
| CALGB-30406 | OTHER | None | None |
| U10CA180821 | NIH | None | None |
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |