Clinical trial · Interventional
Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer
Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
NCT00591149CI-TRIAL-00028115terminatedPhase 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): Study was stopped due to termination of funding
Summary
Brief summary (as posted)
A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous | Squamous Cell Carcinoma | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity.
- interventionNames
- Drug: Oxaliplatin
- Drug: Docetaxel
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Efficacy Measured by Response Rate in Participants
- timeFrame
- 12 Weeks, 1 Year
- description
- Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: * Complete Response (CR), Disappearance of all target lesions; * Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; * Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; * Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed recurrent SCCHN * 18 years or older * Tumor site accessible by biopsy * Measurable disease * Receiving no other therapy * ECOG performance status 0-1 * Adequate bone marrow, renal function and hepatic function Exclusion Criteria: * Active infection or fever within 3 days of treatment * Active CNS metastases * Prior malignancy within 5 years * Hypersensitivity to study drugs * Chemotherapy within 30 days of treatment * Concurrent investigational therapy within 30 days * Radiotherapy of more than 25% of bone marrow * Peripheral neuropathy of grade 2 or greater * Pregnant or lactating patients * History of allogeneic transplant * Active or previously treated HIV or Hepatitis B or C * Patients with a tracheostomy
References
Publications (0)
Data not yet available
No reference posted for this study.