Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042835
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2002-08-05
Brief Title:
Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of OSI-774 NSC 718781-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of erlotinib that can be administered with chest radiotherapy in combination with cisplatin and etoposide or carboplatin and paclitaxel in patients with inoperable stage III non-small cell lung cancer
II Determine the dose-limiting toxicity of these regimens in these patients III Assess the clinical response complete response partial response progressive disease or stable disease in patients treated with these regimens
IV Determine levels of tumor epidermal growth factor expression in patients treated with these regimens
OUTLINE This is a multicenter dose-escalation study of erlotinib Patients are assigned to 1 of 2 treatment groups
GROUP 1 Patients receive cisplatin IV over 2 hours on days 1 8 29 and 36 etoposide IV over 1 hour on days 1-5 and 29-33 and oral erlotinib once daily on days 1-49 Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1 Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50 71 and 92 Some patients may also receive oral erlotinib once daily on days 50-112
GROUP 2 Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21 Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43 50 57 64 71 78 and 85 and oral erlotinib once daily on days 43-91 Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43
In both groups cohorts of 3-6 patients receive escalating doses of erlotinib during concurrent chemoradiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity At least 12 patients from each group are treated at the MTD
Patients are followed at 8 weeks
PROJECTED ACCRUAL A total of 24-48 patients 12-24 per treatment group will be accrued for this study within 6-12 months
I Determine the maximum tolerated dose of erlotinib that can be administered with chest radiotherapy in combination with cisplatin and etoposide or carboplatin and paclitaxel in patients with inoperable stage III non-small cell lung cancer
II Determine the dose-limiting toxicity of these regimens in these patients III Assess the clinical response complete response partial response progressive disease or stable disease in patients treated with these regimens
IV Determine levels of tumor epidermal growth factor expression in patients treated with these regimens
OUTLINE This is a multicenter dose-escalation study of erlotinib Patients are assigned to 1 of 2 treatment groups
GROUP 1 Patients receive cisplatin IV over 2 hours on days 1 8 29 and 36 etoposide IV over 1 hour on days 1-5 and 29-33 and oral erlotinib once daily on days 1-49 Patients undergo concurrent radiotherapy 5 days a week for 7 weeks beginning on day 1 Patients receive consolidation therapy comprising docetaxel IV over 1 hour on days 50 71 and 92 Some patients may also receive oral erlotinib once daily on days 50-112
GROUP 2 Patients receive induction chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21 Patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 43 50 57 64 71 78 and 85 and oral erlotinib once daily on days 43-91 Patients undergo radiotherapy concurrently with consolidation therapy 5 days a week for 7 weeks beginning on day 43
In both groups cohorts of 3-6 patients receive escalating doses of erlotinib during concurrent chemoradiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity At least 12 patients from each group are treated at the MTD
Patients are followed at 8 weeks
PROJECTED ACCRUAL A total of 24-48 patients 12-24 per treatment group will be accrued for this study within 6-12 months
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 |
|---|---|---|---|
| CDR0000069474 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62201 |
| 11432B | None | None | None |
| N01CM17102 | NIH | None | None |
| N01CM62201 | NIH | None | None |