Phase 2
N=37
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00833261 ↗Enrolled (actual)
37
Serious AEs
63.6%
Results posted
Jul 2019
Primary outcome: Primary: Progression Free Survival (PFS) — 60 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Drug); cisplatin (Drug); intensity-modulated radiation therapy (Radiation); Nab-Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
60 | — |
| SECONDARY Number of Participants With Acute and Late Toxicities |
21 | — |
Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
- Recurrent disease or second primary SCC
- Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
- Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
- More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy
- Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)
- No signs of carotid exposure
- No primary nasopharyngeal or salivary gland tumor
- Equivocal pulmonary nodes on chest CT scan allowed provided they are 75 Gy
- No prior chemotherapy for recurrent head and neck cancer
- Prior chemotherapy as a component of the primary treatment allowed
- No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer
- Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment
Data sourced from ClinicalTrials.gov (NCT00833261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.