Clinical trial · Interventional
Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
NCT01794845CI-TRIAL-00027517terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Early termination due to lack of efficacy (overall response)
Summary
Brief summary (as posted)
Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
Conditions
Conditions (3)
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 |
| Recurrent Disease | — | UNRESOLVED | — |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erbitux, Taxotere, LD Fractionated RT
- description
- Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
- interventionNames
- Drug: Erbitux
- Drug: Taxotere
- Radiation: Low Dose Fractionated Radiation Therapy
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) of Participants
- timeFrame
- Up to 6 months from End of Treatment, about 9 months
- description
- ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
Secondary outcomes (3)
- measure
- Number of Study Participants Experiencing Treatment-Related Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥ 6 months following the end of the prior RT. 2. The recurrence must have defined bi- or uni-dimensional measurements. 3. Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence). 4. The patient must not be a candidate for surgical resection. 5. Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy. 6. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine \< 1.5 mg/dl within 3 weeks prior to registration. 9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If \> 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible. 10. Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria: 1. Distant metastases outside of the head and neck. 2. Primary disease in the nasopharynx or the salivary gland. 3. Other concurrent invasive malignancies. 4. Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible). 5. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. 6. Pre-existing grade ≥ 2 peripheral sensory neuropathy 7. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns. 8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.
References
Publications (0)
Data not yet available
No reference posted for this study.