Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288054
Status:
TERMINATED
Last Update Posted:
2013-01-04
First Post:
2006-02-06
Brief Title:
S0429 Docetaxel Cetuximab and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Pilot Phase I Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed early due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Radiation therapy uses high-energy x-rays to kill tumor cells Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Test the feasibility and toxicity of combined cetuximab weekly docetaxel and concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer NSCLC
Secondary
Evaluate response rates confirmed and unconfirmed complete and partial as well as overall and progression-free survival
Correlate EGFR mutations KRAS mutations EGFRHER2 gene copy number detected by FISH and protein expression by immunohistochemistry of EGFR-HER signaling pathways phosphorylation proliferative markers apoptotic markers selected oncogene markers and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and survival outcomes
Explore possible associations between changes in plasma angiogenic factors VEGF IL-8 bFGF and cytokine levels IL-6 IL-1α ICAM TGF-β and others and the risk of treatment-related pneumonitis and esophagitis
OUTLINE Patients are enrolled sequentially to 1 of 2 treatment groups
Cohort 1 Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22
Cohort 2 Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30 minutes on days 8 15 and 22 of course 1 and on days 1 8 15 and 22 of course 2
Initially 27 patients will be enrolled in Cohort 1 Once all patients in Cohort 1 have discontinued treatment if toxicity rates are acceptable per protocol specifications an additional 27 patients will be enrolled to Cohort 2 Treatment in both cohorts repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity All patients also undergo radiotherapy once daily 5 days a week beginning on day 8 of course 1 and continuing through course 2 approximately 7 weeks Patients with no progressive disease then receive cetuximab alone once weekly Treatment with cetuximab alone continues in the absence of disease progression for up to 2 years
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Primary
Test the feasibility and toxicity of combined cetuximab weekly docetaxel and concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer NSCLC
Secondary
Evaluate response rates confirmed and unconfirmed complete and partial as well as overall and progression-free survival
Correlate EGFR mutations KRAS mutations EGFRHER2 gene copy number detected by FISH and protein expression by immunohistochemistry of EGFR-HER signaling pathways phosphorylation proliferative markers apoptotic markers selected oncogene markers and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and survival outcomes
Explore possible associations between changes in plasma angiogenic factors VEGF IL-8 bFGF and cytokine levels IL-6 IL-1α ICAM TGF-β and others and the risk of treatment-related pneumonitis and esophagitis
OUTLINE Patients are enrolled sequentially to 1 of 2 treatment groups
Cohort 1 Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22
Cohort 2 Patients receive cetuximab as in group 1 followed by docetaxel IV over 15-30 minutes on days 8 15 and 22 of course 1 and on days 1 8 15 and 22 of course 2
Initially 27 patients will be enrolled in Cohort 1 Once all patients in Cohort 1 have discontinued treatment if toxicity rates are acceptable per protocol specifications an additional 27 patients will be enrolled to Cohort 2 Treatment in both cohorts repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity All patients also undergo radiotherapy once daily 5 days a week beginning on day 8 of course 1 and continuing through course 2 approximately 7 weeks Patients with no progressive disease then receive cetuximab alone once weekly Treatment with cetuximab alone continues in the absence of disease progression for up to 2 years
After completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0429 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |