Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003089
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
1999-11-01
Brief Title:
Chemotherapy Amifostine and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Induction Paclitaxel Plus Carboplatin Followed by Thoracic Radiation Therapy With Concurrent Weekly Low-Dose Paclitaxel and Twice Weekly Amifostine for Patients With Unresectable Locally Advanced or Partially Resected Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2006-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase II trial to study the effectiveness of paclitaxel carboplatin amifostine and radiation therapy in treating patients who have unresectable locally advanced or partially resected non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel carboplatin amifostine and radiation therapy in treating patients who have unresectable locally advanced or partially resected non-small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the toxic effects and antitumor efficacy of paclitaxel plus carboplatin in patients with unresectable intrathoracic non-small cell lung cancer NSCLC II Integrate concurrent thoracic radiation therapy and weekly low dose paclitaxel into treatment of this patient population III Investigate a primary chemoradiotherapy treatment approach in a population of patients selected on the basis of performance status regardless of degree of weight loss IV Determine the effect of amifostine on the incidence of treatment nonhematologic toxic effects specifically esophagitis pneumonitis and radiation dermatitis in these patients
OUTLINE This is an open label study Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on days 1 and 21 Patients then undergo radiotherapy beginning on day 42 or no later than day 63 daily 5 days a week for 7 weeks Patients also receive amifostine IV over 15 minutes followed by paclitaxel IV over 3 hours weekly day 1 each week concurrently for the duration of radiotherapy On 2 other days of the week patients receive amifostine alone preceding thoracic radiotherapy Patients are followed every 3 months for 1 year and then every 6 months until disease progression or death
PROJECTED ACCRUAL Approximately 15-35 patients will be accrued for this study
OUTLINE This is an open label study Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on days 1 and 21 Patients then undergo radiotherapy beginning on day 42 or no later than day 63 daily 5 days a week for 7 weeks Patients also receive amifostine IV over 15 minutes followed by paclitaxel IV over 3 hours weekly day 1 each week concurrently for the duration of radiotherapy On 2 other days of the week patients receive amifostine alone preceding thoracic radiotherapy Patients are followed every 3 months for 1 year and then every 6 months until disease progression or death
PROJECTED ACCRUAL Approximately 15-35 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 |
|---|---|---|---|
| NCI-V97-1343 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065792 | REGISTRY | None | None |
| ALZA-97-019-ii | None | None | None |