Efficacy and Safety of TC+AVASTIN Versus TC in Patients With Metastatic Nasopharyngeal Carcinoma

Conditions

• Nasopharyngeal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle
• Bevacizumab — DRUG
  Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle
• Carboplatin — DRUG
  Carboplatin AUC 6 IV Day 1 each 3-week cycle

Study Details

The present study will be a randomized, control, multicenter phase II study of metastatic nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H\&N35 are used to measure PRO outcome for this study.

Key Dates

First listed

Sep 26, 2014

Start date

Aug 31, 2014

Status verified

Dec 2015

Primary completion

Apr 30, 2016

Completion

Dec 31, 2016

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: carboplatin and paclitaxel
  carboplatin and paclitaxel :paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle
• Experimental: AVASTIN and carboplatin and paclitaxel
  AVASTIN and carboplatin and paclitaxel: Bevacizumab(AVASTIN) 7.5 mg/kg intravenously (IV) infusion on Day 1 of each 3-week cycle; paclitaxel 175 mg/m2 IV and carboplatin AUC 6 IV on Day 1 of each 3-week cycle

Primary Outcome Measure

Progression free survival(PFS) [ Time Frame: 3 years ]