Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004094
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Advanced Cancer of the Mouth Pharynx or Larynx
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel 1 Hour Infusion Fluorouracil Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral Pharynx and Larynx Cancer
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_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:
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 radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth pharynx or larynx
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated advanced cancer of the mouth pharynx or larynx
Detailed Description:
OBJECTIVES
Evaluate the activity of induction chemotherapy with carboplatin and paclitaxel followed by concurrent fluorouracil hydroxyurea paclitaxel and hyperfractionated radiotherapy in terms of response rate pattern of failure time to progression and overall survival in patients with previously untreated advanced oral pharyngeal or laryngeal cancer
Assess this treatment regimen in terms of the pattern and degree of clinical acute cumulative and chronic toxic effects in this patient population
Assess the rate of organ preservation in resectable patients treated with this regimen
Evaluate the quality of life organ function and incidence of second primary tumors in patients treated with this regimen
Assess the rate of complications with subcutaneously implanted IV infusion catheters in patients treated with this regimen
OUTLINE Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes weekly for 3 weeks Treatment repeats every 4 weeks for 2 courses
At 1-2 weeks after completion of induction chemotherapy patients receive oral hydroxyurea every 12 hours on days 1-6 fluorouracil IV continuously on days 1-5 radiotherapy twice daily on days 1-5 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 2 weeks for 5 courses
Patients with residual nodal disease or initially staged nodal disease in the absence of macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy Patients with residual disease at the primary site undergo complete excision of disease Patients with disease progression or disease recurrence are considered for conventional surgical management
Quality of life is assessed every 3 months for 6 months every 6 months for 15 years and then annually thereafter
Patients are followed monthly for 1 year every 2 months for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 12-18 months
Evaluate the activity of induction chemotherapy with carboplatin and paclitaxel followed by concurrent fluorouracil hydroxyurea paclitaxel and hyperfractionated radiotherapy in terms of response rate pattern of failure time to progression and overall survival in patients with previously untreated advanced oral pharyngeal or laryngeal cancer
Assess this treatment regimen in terms of the pattern and degree of clinical acute cumulative and chronic toxic effects in this patient population
Assess the rate of organ preservation in resectable patients treated with this regimen
Evaluate the quality of life organ function and incidence of second primary tumors in patients treated with this regimen
Assess the rate of complications with subcutaneously implanted IV infusion catheters in patients treated with this regimen
OUTLINE Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes weekly for 3 weeks Treatment repeats every 4 weeks for 2 courses
At 1-2 weeks after completion of induction chemotherapy patients receive oral hydroxyurea every 12 hours on days 1-6 fluorouracil IV continuously on days 1-5 radiotherapy twice daily on days 1-5 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 2 weeks for 5 courses
Patients with residual nodal disease or initially staged nodal disease in the absence of macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy Patients with residual disease at the primary site undergo complete excision of disease Patients with disease progression or disease recurrence are considered for conventional surgical management
Quality of life is assessed every 3 months for 6 months every 6 months for 15 years and then annually thereafter
Patients are followed monthly for 1 year every 2 months for 1 year and then every 3 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 12-18 months
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-G99-1587 | None | None | None |
| NU-C98N1 | None | None | None |
| UCCRC-9502 | None | None | None |