Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040794
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy Radiation Therapy and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
ZD1839 NSC 715055 IND 61187 With Induction Paclitaxel And Carboplatin Followed By Either Radiation Or Concomitant Radiation With Weekly Paclitaxel And Carboplatin In Stage III Non-Small Cell Lung Cancer A Phase II Study
Status:
COMPLETED
Status Verified Date:
2013-06
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 phase II clinical trial studies how well combining different regimens of chemotherapy and gefitinib with radiation therapy work in treating patients with stage III non-small cell lung cancer Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of non-small cell lung cancer Radiation therapy uses high-energy x-rays to damage tumor cells Giving different regimens of combination therapy together with gefitinib and radiation therapy may be an effective treatment for non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether ZD1839 gefitinib at 250 mg orally every day administered concomitantly with radiotherapy after induction treatment consisting of paclitaxel carboplatin and ZD1839 among patients with inoperable stage III non-small cell lung cancer and Common Terminology Criteria CTC performance status 2 or poor risk performance status 0-1 is tolerable
II To determine whether ZD1839 at 250 mg orally every day administered concomitantly with paclitaxel carboplatin and radiation after induction treatment consisting of paclitaxel carboplatin and ZD1839 among patients with inoperable stage III non-small cell lung cancer and CTC performance status 0-1 is tolerable
III To determine the overall response rate failure-free survival and survival after treatment with induction chemotherapy with daily ZD1839 concomitant radiotherapy and daily ZD1839 and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 2 or poor risk performance status 0-1 and inoperable stage III non-small cell lung cancer
IV To determine the overall response rate failure-free survival and survival after treatment with induction chemotherapy and daily ZD1839 concomitant chemoradiotherapy and daily ZD1839 and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 0-1 and inoperable stage III non-small cell lung cancer
V To determine if elevated circulating epidermal growth factor receptor EGFR levels prior to treatment as determined by either quantitative polymerase chain reaction PCR or direct enzyme-linked immunosorbent assay ELISA measurement may predict for response to therapy with EGFR inhibitors
OUTLINE
All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive therapy based on their assigned stratum
STRATUM I Patients receive gefitinib orally PO daily for 7 weeks Patients also undergo concurrent radiotherapy once daily 5 days a week for 7 weeks
STRATUM II Patients receive gefitinib and radiotherapy as in stratum I concurrently with paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks
Patients then receive gefitinib PO daily in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months for 2 years
I To determine whether ZD1839 gefitinib at 250 mg orally every day administered concomitantly with radiotherapy after induction treatment consisting of paclitaxel carboplatin and ZD1839 among patients with inoperable stage III non-small cell lung cancer and Common Terminology Criteria CTC performance status 2 or poor risk performance status 0-1 is tolerable
II To determine whether ZD1839 at 250 mg orally every day administered concomitantly with paclitaxel carboplatin and radiation after induction treatment consisting of paclitaxel carboplatin and ZD1839 among patients with inoperable stage III non-small cell lung cancer and CTC performance status 0-1 is tolerable
III To determine the overall response rate failure-free survival and survival after treatment with induction chemotherapy with daily ZD1839 concomitant radiotherapy and daily ZD1839 and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 2 or poor risk performance status 0-1 and inoperable stage III non-small cell lung cancer
IV To determine the overall response rate failure-free survival and survival after treatment with induction chemotherapy and daily ZD1839 concomitant chemoradiotherapy and daily ZD1839 and post-radiotherapy single agent daily ZD1839 among patients with CTC performance status 0-1 and inoperable stage III non-small cell lung cancer
V To determine if elevated circulating epidermal growth factor receptor EGFR levels prior to treatment as determined by either quantitative polymerase chain reaction PCR or direct enzyme-linked immunosorbent assay ELISA measurement may predict for response to therapy with EGFR inhibitors
OUTLINE
All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients then receive therapy based on their assigned stratum
STRATUM I Patients receive gefitinib orally PO daily for 7 weeks Patients also undergo concurrent radiotherapy once daily 5 days a week for 7 weeks
STRATUM II Patients receive gefitinib and radiotherapy as in stratum I concurrently with paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks
Patients then receive gefitinib PO daily in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year and then every 6 months for 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-30106 | None | None | None |
| CDR0000069407 | None | None | None |