Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 11:48 AM
Study NCT ID:
NCT00497250
Status:
UNKNOWN
Last Update Posted:
2008-10-21
First Post:
2007-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
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:
The primary objective of this study is to evaluate the tolerability and the maximum tolerated dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy.
Secondary objectives of the study are to obtain the preliminary information on efficacy after concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria.
To determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
Secondary objectives of the study are to obtain the preliminary information on efficacy after concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria.
To determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
Detailed Description:
Laboratory research has suggested that targeting specific signalling proteins would be well suited for selectively enhancing the tumor radiosensitivity. In human xenograft models (non-small cell lung cancer and breast cancer) treated with gefitinib and irradiation, combined therapy has shown a significant increase in tumor growth delay as compared with monotherapy of irradiation or gefitinib. The epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 selectively potentiates radiation response of human tumors in nude mice, with a marked improvement in therapeutic index. The authors concluded that gefitinib profoundly enhanced the antitumor action of RT against the tested tumors without significant adverse effects, increasing the therapeutic selectively of ionizing radiation in certain model systems. Substantial benefits for this multimodality therapy in patients could be expected.
While there are no published data on the feasibility and efficacy of combined gefitinib and radiation therapy in Chinese population who might be susceptible to gefitinib monotherapy, clinical studies have demonstrated that combining gefitinib with external beam radiation to 66-74Gy and concurrent weekly chemotherapy after induction chemotherapy were tolerated without excessive toxicity. In the present trail, we hope to build on our own experience of using combined gefitinib and thoracic radiation with 3D-CRT or intensity-modulated radiotherapy (IMRT) technique in a phase I setting for stage IIIb and selected stage IV NSCLC. We will follow this treatment (RT and gefitinib) with 60 days gefitinib at standard systemic doses.
While there are no published data on the feasibility and efficacy of combined gefitinib and radiation therapy in Chinese population who might be susceptible to gefitinib monotherapy, clinical studies have demonstrated that combining gefitinib with external beam radiation to 66-74Gy and concurrent weekly chemotherapy after induction chemotherapy were tolerated without excessive toxicity. In the present trail, we hope to build on our own experience of using combined gefitinib and thoracic radiation with 3D-CRT or intensity-modulated radiotherapy (IMRT) technique in a phase I setting for stage IIIb and selected stage IV NSCLC. We will follow this treatment (RT and gefitinib) with 60 days gefitinib at standard systemic doses.
Study Oversight
Has Oversight DMC:
True
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?: