Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001499
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2000-03
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:
2-Drug Combination Chemotherapy Followed by Radiotherapy Paclitaxel TAX NSC-125973 Cisplatin CDDP NSC-119875 followed by chest irradiation using 4-15 MV photons
Detailed Description:
This is a Phase II study of paclitaxel administered as a 96-hour 4 day continuous infusion with a bolus of cisplatin followed by chest radiotherapy for previously untreated patients with stage III non-small cell lung cancer NSCLC The non-small cell lung cancer tissue obtained prior to the start of treatment will be studied for mutations of the p53 gene The goal of this phase II study is to determine the response rate to 4 cycles of infusional paclitaxel and bolus cisplatin for patients with stage III NSCLC The response will again be assessed following completion of 6000 cGy of chest radiotherapy and the patients will then be followed for survival The relationship between the presence or absence of a p53 mutation and the sensitivity of the patients tumors to paclitaxel plus cisplatin and chest radiation will be studied In addition the plasma levels of paclitaxel will be measured and the in vitro paclitaxel chemosensitivity of the tumor cells will be determined from as many patients as possible This will allow further study of the relationship between p53 status in vitro drug sensitivity achievable plasma concentrations of paclitaxel and patients response to therapy
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 |
|---|---|---|---|
| 96-C-0054 | None | None | None |