Clinical trial · Interventional
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
NCT00833261CI-TRIAL-00046751completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm: Chemotherapy with Concurrent Radiation therapy
- description
- Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy
- interventionNames
- Drug: cetuximab
- Drug: cisplatin
- Radiation: intensity-modulated radiation therapy
- Drug: Nab-Paclitaxel
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 2 year from the date of enrollment
- description
- The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 \< 1 cm, cannot be safely biopsied, or are negative on PET scan * No distant metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) * Bilirubin \< 1.5 mg/dL * AST or ALT \< 2 times upper limit of normal * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded * No active cardiac disease, including any of the following: * Unstable angina * Uncontrolled hypertension * Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) * Uncontrolled arrhythmia * Congestive heart failure * At least 3 heart-related hospitalizations within the past year * No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year * No concurrent medical illness that would impair patient tolerance to therapy or limit survival * No other invasive malignancy within the past 2 years * No pre-existing peripheral sensory neuropathy ≥ grade 2 * No prior severe infusion reaction to a monoclonal antibody * No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * Prior cisplatin and cetuximab allowed * At least 6 months since prior radiotherapy or chemotherapy * No prior radiotherapy \> 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
References
Publications (1)
- DERIVEDAwan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018. PMID 29346519