Clinical trial NCT00226239: Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer
Official title: A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: head
neck
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.

Detailed description: This research study involves the use of a combination of two chemotherapies, cisplatin and docetaxel, which have been known to shrink head and neck cancers and are a commonly used treatment for this type of cancer. This combination will then be followed by radiation and more chemotherapy.

The purpose of this study is to see whether this combination of chemotherapy and radiation, with the addition of Cetuximab, can improve control of disease and collect information on what side effects this combination therapy may have. In addition, biologic factors (markers) will be studied that may help to predict and treat head and neck cancer patients in the future.

Eligibility criteria: Inclusion Criteria:

1. Stage III-IVB head and neck cancer, all sites, including unknown primary tumors (bulky stage II (T2N0) lesions of the base of tongue or hypopharynx and patients with stage II nasopharyngeal cancer are also eligible) Prior to study entry the resectability and alternative treatment options will be determined by a team composed of an Ear, Nose, and Throat Surgeon, a Radiation Oncologist and a Medical Oncologist. Stage determination, optimal local treatment, and its timing according to this protocol will be determined at this evaluation. Unequivocal demonstration of distant metastasis (M1) confers ineligibility
2. Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas, or WHO types I-III of the nasopharynx
3. Unidimensionally-measurable disease is required (RECIST)
4. No prior chemotherapy, biologic/molecular targeted therapy (including any prior therapy which specifically and directly targets the EGFR pathway), or radiotherapy for head and neck cancer
5. Prior surgical therapy will consist only of incisional or excisional biopsy and organ sparing procedures such as debulking of airway compromising tumors or neck dissection in a patient with an existing primary tumor (Any non-biopsy procedure must have taken place \> 4 weeks but \< 3 months of initiating protocol treatment)
6. ECOG PS 0 or 1; 7. Organ \& marrow function per protocol criteria and 8. Age of \>=18 years

Exclusion Criteria:

1. History of severe allergic reactions attributed to docetaxel or compounds of similar chemical or biologic composition to docetaxel, or other drugs formulated with polysorbate 80
2. Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
3. Receiving any other investigational agents
4. No history of prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 5-year disease-free survival
5. Significant baseline sensory or motor neurologic deficits (\> grade I neuropathy); 6. HIV-positive patients and 7. Prior severe infusion reaction to a monoclonal antibody.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 36 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 36 months
measure: 2-year Overall Survival (OS)
timeFrame: Up to 24 months
measure: 3-year Overall Survival (OS)
timeFrame: Up to 36 months
measure: Quality of Life (QOL)
timeFrame: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
Other outcomes:
measure: EGFR-related Serum Markers
timeFrame: Up to 36 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Univ of Pittsburgh
name: Julie Bauman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.