Phase II Trial of Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma

Memorial Sloan Kettering Cancer Center5 sites in 1 country30 target enrollmentAugust 2009

ConditionsHead and Neck Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 30
Locations: 5
Primary Endpoint: To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effectiveness of treatment with bevacizumab + cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the completion of study treatment to determine if they are cancer-free during that time. They also want to evaluate the side effects that patients experience with this treatment regimen.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Stage III/IV HNSCC without distant metastasis. Patients with stage II squamous cell carcinoma of the hypopharynx will also be eligible
•Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine \> 1.5 mg/dL may be eligible if calculated creatinine clearance \> or = to 55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection).
•Age \> or = to 18 years.
•Karnofsky performance status \> or = to 70%
•Adequate bone marrow function: absolute neutrophil count \> or = to 1,500/ platelets \> or = to 100,000/ul, hemoglobin \> or = to 9 gm/dl
•Adequate hepatic function: Total bilirubin ≤ 1.5 X ULN (patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X ULN), aspartate aminotransferase (AST) ≤ 2.5 X ULN, alanine aminotransferase (ALT) ≤ 2.5 X ULN, alkaline phosphatase ≤ 2.5 X ULN.
•Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
•Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•Prior radiation therapy for HNSCC
•Prior treatment of HNSCC with bevacizumab or other agents specifically targeting VEGF
•Prior treatment of HNSCC with cetuximab or other agents specifically targeting EGFR
•Other active malignancy, other than indolent malignancies, which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.
•Patients with nasopharyngeal carcinoma
•Patients who will receive amifostine as part of the radiation treatment plan
•Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).
•Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinically significant way with activities of daily living).
•Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).
•Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)

Outcomes

Primary Outcomes

To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.

Time Frame: 2 years

Secondary Outcomes

To determine median overall survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.(2 years)
To evaluate the safety and tolerability of concurrent IMRT + cisplatin + bevacizumab + cetuximab.(2 years)
To explore the potential utility of 18F FLT PET for early response assessment.(2 years)