Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Pati… (NCT01927744) | Clinical Trial Compass
CompletedPhase 2
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection
United States55 participantsStarted 2013-12-16
Plain-language summary
The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.
In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.
✓. Patients must have surgically resectable disease, in the opinion of the treating physician
✓. Age ≥ 18 years.
✓. ECOG PS ≤ 2 (Appendix C)
✓. Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;
Exclusion criteria
✕. Histology other than squamous cell carcinoma.
✕. Primary sites other than oral cavity.
✕. Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
✕. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted
What they're measuring
1
Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis)
Timeframe: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).
✕. Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma.
✕. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
✕. History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80.
✕. Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer.