Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00343083 | Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442) | PHASE2 | COMPLETED | 43 | — | — | Dec 1, 2004 | May 1, 2012 | Aug 19, 2019 | 1 | United States |
The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.
| Arm | Type | Description |
|---|---|---|
| Cetuximab comparison for Head and Neck Cancer | EXPERIMENTAL | To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT). Both chemotherapy and radiation will be given on a weekly basis (see interventions for details). |
| Name | Type | Description |
|---|---|---|
| Erbitux, Paclitaxel & Carboplatin | DRUG | Paclitaxel, 40 mg/m2/week, 1-hour infusion (weeks 2-9.Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour infusion prior to cetuximab dose. Cetuximab: 400 mg/m2 IV (initial dose) week 1 then 250 mg/m2 IV weekly for 8 weeks weeks 2-9). Cetuximab will be administered 400mg/m2 IV on Day 1, then the first 250 mg/m2 IV dose will be given on day 8 (week 2) prior to carboplatin dose. Carboplatin, AUC=2/week as a 30 minute infusion after cetuximab infusion (weeks 2-9)Carboplatin will be administered at a dose of AUC = 2/week IV bolus each week and will be administered prior to head and neck irradiation dose. (Carboplatin: AUC=2/week x 8 weeks (weeks 2-9) |
| Radiation | RADIATION | XRT=Radiotherapy 1.8 Gy radiation/day, 5 days a week for a total of 70.2 Gy.(weeks 2-9) - IMRT is allowed |
Inclusion Criteria: 1. Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses, Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinu...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 1 | PHASE1 | TG4001, Avelumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |