Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021333
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2001-07-11
Brief Title:
Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck And Lung
Status:
COMPLETED
Status Verified Date:
2013-04
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy
PURPOSE Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer
Detailed Description:
OBJECTIVES I Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim G-CSF II Assess the toxicity of this regimen in these patients III Determine the time to progression and the sites and pattern of progression in patients treated with this regimen IV Determine the median 1-year and 2-year survival rates of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to disease squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5 Patients undergo radiotherapy twice daily on days 1-5 Patients receive filgrastim G-CSF subcutaneously on days 6-13 or until blood counts recover Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 2 months
PROJECTED ACCRUAL A total of 42-84 patients 14-28 per stratum will be accrued for this study within 2-4 years
OUTLINE This is a multicenter study Patients are stratified according to disease squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5 Patients undergo radiotherapy twice daily on days 1-5 Patients receive filgrastim G-CSF subcutaneously on days 6-13 or until blood counts recover Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 2 months
PROJECTED ACCRUAL A total of 42-84 patients 14-28 per stratum will be accrued for this study within 2-4 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 |
|---|---|---|---|
| NCI-G01-1983 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-99025 | None | None | None |