A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study involves two phases. Phase I of this study is designed to find out the maximum dose of paclitaxel poliglumex which can be safely given to subjects when combined with cetuximab and radiotherapy in head and neck cancer. Once the maximum safe dose of paclitaxel poliglumex is found, Phase II of the study will continue to find out whether the addition of paclitaxel poliglumex increases tumor response and survival compared to treatment with cetuximab and radiotherapy alone.

An additional 20 patients have been added, to balance data. These patients must be HPV negative.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Collaborator: CTI BioPharma
• Treatments: Albumin-Bound Paclitaxel; Cetuximab; Paclitaxel; Paclitaxel poliglumex

Criteria

Inclusion Criteria:

• Patients with histological proof (from the primary lesion and/or cervical lymph node) of squamous carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.

• Patients should have stage III or IV disease

• Patients must have ECOG Performance Status of 0-1

• Patients must be >/= 18 years of age

• Patients must have measurable disease

• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100,000 cells/ mm3; adequate hepatic function with bilirubinupper limit of normal; serum creatinine/= 50 ml/min and INR 0.8 - 1.2

• Patients must sign a study specific informed consent form prior to study entry

• Final 20 subjects must be HPV negative

Exclusion Criteria:

• Histology other than squamous cell carcinoma

• Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations for phase II study subjects

• History of malignancy other than non-melanoma skin cancer

• Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy

• Prior history of allergy or hypersensitivity to cetuximab or paclitaxel

• Weight loss > 10% in the past three months

• Patients with uncontrolled intercurrent disease

• Patients with currently active malignancy

• Pregnant or lactating women

• Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug