Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

October 16, 2017

Study Completion Date

October 16, 2017

Conditions
Head and Neck CancerSquamous Cell Cancer
Interventions
DRUG

Afatinib, Ribavirin, and weekly carboplatin/paclitaxel

Patients will receive oral daily afatinib (days 1 - 21, per dose escalation scheme) plus daily oral ribavirin (days 1- 21) and paclitaxel (80 mg/m2 intravenously, days 1 and 8) + carboplatin (AUC 1.5 intravenously, days 1 and 8) of a 21-day cycle. Ribavirin will be administered according to standard weight-based dosing for this drug (1). Subjects ≤75 kg receive Ribavirin 400 mg PO qAM and 600 mg PO qPM (= 1000 mg/day). Subjects \> 75 kg receive Ribavirin 600 mg PO BID (=1200 mg/day). During the Dose Escalation portion of the study (Part 1), research bloodwork for pharmacokinetics is performed on days 1 and 8 of Cycle 1 only.

Trial Locations (2)

10065

Memorial Sloan Kettering Cancer Center, New York

07939

Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Comprehensive Cancer Network

NETWORK

collaborator

Boehringer Ingelheim

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01721525 - Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC) | Biotech Hunter | Biotech Hunter