Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ph II Trial of Induction Chemotherapy With Carboplatin and Paclitaxel, Followed by Concurrent Chemotherapy/Radiation Therapy With ZD1839 (IRESSA), 5-FU, Hydroxyurea, and Twice-Daily Radiation, Followed by Adjuvant ZD1839 Monotherapy in Patients With Locally Advanced Head & Neck Cancer|
- Activity is described in terms of response rate (complete responses only) [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]To explore the activity of ZD1839 added to concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck cancer. Activity is described in terms of response rate (complete responses only).
- Tolerability and Feasibility of ZD1839 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To explore the tolerability and feasibility of ZD1839 added to concurrent chemoradiotherapy.
- To assess quality of life (QoL)
- To define any toxcities of ZD1839 used in concurrent chemoradiotherapy and as adjuvant therapy
• To assess pharmacodynamics of ZD1839 in vivo and correlate clinical outcome with inhibition of tyrosine kinase activity
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: ZD1839 500mg by mouth (po) daily
Single arm, two-stage, phase II trial of induction therapy with carboplatin and paclitaxel, followed by ZD1839, 5-FU, hydroxyurea, and hyperfractionated radiotherapy, followed by adjuvant ZD1839 alone.
Drug: ZD 1839 500mg
Optional Induction chemotherapy:
Carboplatin and paclitaxel combination will be administered for 2 cycles of 4 weeks duration each. Paclitaxel: 100 mg/m2 in 500 ml of dextrose 5% in water over 3hrs. Carboplatin: Start after completion of paclitaxel on Day 1 AUC 6 (creatinine clearance [CC] + 25). Administered in 100 ml of normal saline over 30min after completion of paclitaxel.
Resume chemotherapy C2 on D29. ZD1839: 500mg PO QD from D1 of C1 of chemoradiotherapy, uninterrupted until disease progression. Chemotherapy should be administered during all 5 weeks of radiotherapy. P.M.:Start hydroxyurea at 500 mg PO q 12hrs × 6 days. The first daily dose of hydroxyurea on Days 1 through 5 is given 2 hours prior to the first fraction of daily radiotherapy. P.M.:Start continuous infusion of 5-FU at 600 mg/m2/day × 5D. Days 1 through 5: Radiation therapy is administered twice daily at 150 cGy ZD1839 will be administered from day 1 to 14 of every chemoradiotherapy cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185171
|United States, Illinois|
|The University of Chicago Medical Center|
|Chicago, Illinois, United States, 60653|
|Principal Investigator:||Everett Vokes, MD||The University of Chicago Medical Center|