Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020709
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of CisplatinEtoposideRadiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy With ZD1839 NSC-715055 or Placebo in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer
Detailed Description:
OBJECTIVES
I To assess whether maintenance therapy with ZD1839 as compared to placebo following induction cisplatinetoposideradiotherapy plus consolidation docetaxel improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer NSCLC
II To describe the toxicity profile of long term administration of ZD1839 III To obtain samples for correlative studies
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to performance status 0 vs 1 stage stage IIIA vs IIIB measurability of lesion measurable vs nonmeasurable and histologic subtype squamous vs nonsquamous
Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Beginning within 24 hours after starting chemotherapy patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 15 weeks
Beginning approximately 4-8 weeks after completion of chemoradiotherapy patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 3 courses
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy
Arm I Patients receive oral gefitinib daily
Arm II Patients receive oral placebo daily In both arms maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 5 years and then annually for 5 years
I To assess whether maintenance therapy with ZD1839 as compared to placebo following induction cisplatinetoposideradiotherapy plus consolidation docetaxel improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer NSCLC
II To describe the toxicity profile of long term administration of ZD1839 III To obtain samples for correlative studies
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to performance status 0 vs 1 stage stage IIIA vs IIIB measurability of lesion measurable vs nonmeasurable and histologic subtype squamous vs nonsquamous
Patients receive induction therapy comprising cisplatin IV over 1 hour on days 1 8 29 and 36 and etoposide IV over 1 hour on days 1-5 and 29-33 Beginning within 24 hours after starting chemotherapy patients receive concurrent induction radiotherapy 5 days a week for 5 weeks and then boost radiotherapy 5 days a week for 15 weeks
Beginning approximately 4-8 weeks after completion of chemoradiotherapy patients with stable or responding disease receive consolidation therapy comprising docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 3 courses
Patients with stable or responding disease are randomized to one of two treatment arms for maintenance therapy Patients begin maintenance therapy approximately 4-7 weeks after completion of consolidation therapy
Arm I Patients receive oral gefitinib daily
Arm II Patients receive oral placebo daily In both arms maintenance therapy continues for a maximum of 5 years in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 5 years and then annually for 5 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 |
|---|---|---|---|
| CDR0000068706 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0023 | None | None | None |
| U10CA032102 | NIH | None | None |