Clinical trial · Interventional
Abraxane in Combination With Carboplatin, Erbitux and IMRT for Locally Advanced Squamous Cancer of the Head and Neck
A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study did not continue to phase II due to the importance of HPV status as a prognostic factor to guide treatment decisions.
Summary
Brief summary (as posted)
The purpose of the Phase I part of this research study is to determine the safest and most effective dose of Abraxane when given in combination with carboplatin and Erbitux during radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is to determine the effects of the treatment on head and neck cancers, as well as to further study the safety of this treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenosquamous Cell Carcinoma | Adenosquamous Carcinoma | PROBABILISTIC | 0.70 |
| Basaloid Squamous Cell Carcinoma | Basaloid Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
| Undifferentiated Carcinoma | Undifferentiated Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane | Drug | Paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Erbitux | Drug | Cetuximab | ALIAS |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase I Dose Level 1: ACE-RT
- description
- Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
- interventionNames
- Drug: Abraxane
- Drug: Erbitux
- Drug: Carboplatin
- Radiation: Intensity Modulated Radiation Therapy
- type
- EXPERIMENTAL
- label
- Phase I Dose Level -1: AC-RT
- description
- Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven squamous cell carcinoma of th head and neck or its variants. Primary tumor sites eligible include nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary SSCHN. Although they have squamous histology, tumors of the skin, nasal cavity and paranasal sinuses are excluded because their responsiveness to chemotherapy and radiotherapy may differ. * Stage III or IV disease, without evidence of distant metastasis, according to the American Joint Committee on Cancer. * Measurable disease, according to RECIST. * Treatment-naive SSCHN, i.e. no prior chemotherapy, radiotherapy or attempted complete resection. * \< CTCAE v3.0 Grade 2 neuropathy * 18 years of age or older * ECOG Performance Status of 0 or 1 * No active alcohol addiction or other condition that, in the opinion of the study investigators, would interfere with the subject's ability to comply with the treatment plan. * Lab values as outlined in the protocol * Negative pregnancy test within 7 days of study entry Exclusion Criteria: * Pregnant or breast-feeding women, or women and men of childbearing potential not willing to use adequate contraception while receiving treatment and for at least 6 months thereafter. * Symptomatic peripheral neuropathy Grade 2 or greater by CTCAE v3.0 * History of other malignancy within the previous 5 years, except for non-melanoma skin cancer, carcinoma in situ of the cervix, bladder or head and neck. * Prior therapeutic radiation to the head and neck * Other serious illness or medical conditions, including but not limited to: unstable cardiac disease or myocardial infarction within 6 months prior to study entry; history of significant neurologic disorder, including advanced dementia or uncontrolled seizure disorder; clinically significant uncontrolled infection; active peptic ulcer disease defined as unhealed or clinically active ulcer; hypercalcemia; active drug addiction including cocaine or intravenous drug use, defined as occuring within 6 months preceding diagnosis; chronic obstructive pulmonary disease; autoimmune disease requiring active therapy; severe psoriasis; chronic uncontrolled diarrhea. * Patients who experienced involuntary weight loss of more than 20% of their body weight in the two months preceding study entry * Concurrent treatment with any other anticancer therapy * Prior therapy that targets the EGFR pathway * Participation in an investigational drug trial within 30 days of study entry
References
Publications (0)
Data not yet available