NCT01309633 - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 2, 2011

Primary Completion Date

March 11, 2019

Study Completion Date

March 11, 2019

Conditions

Nasopharyngeal Carcinoma

Interventions

DRUG

12.5mg sunitinib with Cisplatin and Gemcitabine

"1\) Arm A~Day -6 to Day 0 (total 7 days):~Sunitinib 12.5mg daily Cycles 1 and 2 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 Day 15 to Day 21: Sunitinib 12.5mg daily Cycle 3 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2"

DRUG

25mg Sunitinib alternating with Cisplatin and Gemcitabine

"Arm B~Day -6 to Day 0 (total 7 days):~Sunitinib 25mg daily Cycles 1 and 2 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 Day 15 to Day 21: Sunitinib 25mg daily Cycle 3 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2"

DRUG

7.5mg/kg Bevacizumab alternating with Cisplatin and Gemcitabine

Day -7: IV bevacizumab 7.5mg/kg diluted in normal saline over 30 minutes Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 For locally advanced patients, 3 cycles of treatment will be administered. For metastatic patients, up to 6 cycles would be administered.

DRUG

2.5mg/kg Bevacizumab alternating with Cisplatin and Gemcitabine

Day -7: IV bevacizumab 2.5mg/kg diluted in normal saline over 30 minutes Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 For locally advanced patients, 3 cycles of treatment will be administered. For metastatic patients, up to 6 cycles would be administered

Trial Locations (1)

119074

National University Hospital, Kent Ridge

All Listed Sponsors

lead

National University Hospital, Singapore

OTHER