A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer (ECOG E1305)

Conditions

Head and Neck Cancer

What is the purpose of this trial?

Three regimens on this trial stratified by ECOG PS, Weight Loss, Prior Radtn to HN, Chemo Regimen.  Regimens are as follows:

Regimen 1: Docetaxel 75 mg/m2 IV over 1 hour, day 1, followed by Cisplatin 75 mg/m2 IV over 1-2 hours, day 1,every 21 days. Prophylactic ciprofloxacin 500 mg twice daily, orally, on days 5-14. Regimen 1 carbo: Docetaxel 75 mg/m2 IV over 1 hour, day 1, followed by Carboplatin AUC 6 over 30 min., day 1, every 21 days. Prophylactic ciprofloxacin 500 mg twice daily, orally, on days 5-14. Regimen 2: Cisplatin 100 mg/m2 IV over 1-2 hours on day 1, followed by 5-FU 1000 mg/m2 /day as a continuous infusion x 4 days, every 21 days. Prophylactic ciprofloxacin 500 mg twice daily, orally, on days 5-14. Regimen 2 carbo: Carboplatin AUC 6 over 30 min., day 1, followed by 5-FU 1000 mg/m2 /day as a continuous infusion x 4 days, every 21 days. Prophylactic ciprofloxacin 500 mg twice daily, orally, on days 5-14. NOTE: Chemotherapy regimen choice will be at the discretion of the treating physician and will be made prior to randomization. NOTE: If maximum response, option to discontinue chemotherapy treatment after 6 cycles.


Participation Guidelines

Age:
18 and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Eastern Cooperative Oncology Group
Dates:
8/25/2011
Last Updated:
Study HIC#:
1103008120

Clinicaltrials.gov ID: Yale1942669