Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer

NCT ID: NCT00405405

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-06-30

Brief Summary

To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer

Detailed Description

Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.

The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.

Conditions

Head and Neck Cancer; Parotid Gland Cancer; Thyroid Gland Cancer; Melanoma; Stage IV Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Docetaxel

Intervention Type: DRUG

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Bevacizumab

Intervention Type: DRUG

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Erlotinib

Intervention Type: DRUG

• Two cycles during neoadjuvant therapy (dose escalation)
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Radiotherapy

Intervention Type: RADIATION

Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks

Interventions

Cisplatin

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Intervention Type: DRUG

Docetaxel

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Intervention Type: DRUG

Bevacizumab

• Two cycles during neoadjuvant therapy
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Intervention Type: DRUG

Erlotinib

• Two cycles during neoadjuvant therapy (dose escalation)
• Response assessment at approximately day 36
• Concurrent biochemoradiotherapy

Intervention Type: DRUG

Radiotherapy

Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks

Intervention Type: RADIATION

Other Intervention Names

cisplatinum; cis-diamminedichloroplatinum(II); CDDP; Platinol; Platinol-AQ; Taxotere; Avastin; Erlotinib hydrochloride; Tarceva; Radiation therapy; Radiation oncology; XRT

Eligibility Criteria

Inclusion Criteria

• Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
• Stage IV disease (T4Nany or TanyN2-3).
• "Oligometastatic" disease is allowable if it is asymptomatic.
• Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is <40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
• Performance status 0-1.
• Creatinine < or = 1.5 mg/dl.
• ANC > or = 1,800 cells/mm3.
• Platelets > or = 150,000 cells/mm3.
• Hemoglobin > or = 10 g/dl (transfusion is acceptable if needed).
• SGOT and/or SGPT < or = 2.5 times the upper institutional limit of normal.
• INR < or = 2.0.
• Age > or = 18 (informed consent).

Exclusion Criteria

• Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
• Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
• Unstable angina.
• NY Heart Association (NYHA) Grade II or greater congestive heart failure.
• History of myocardial infarction or stroke within 6 months.
• Clinically significant peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• Presence of brain or spinal cord metastases.
• Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.
• Urine protein: Creatinine ratio > or = 1.0 at screening.*
• Carotid artery exposure or other signs of impending carotid artery hemorrhage.
• History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
• Serious, non-healing wound, ulcer, or bone fracture.
• Prior irradiation that would result in radiotherapy field "overlap."
• Requirement for high dose oral anticoagulation (i.e., goal INR > 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.
• No known allergies to any of the drug therapies being used in this protocol.
• No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pramila Rani Anne, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.KimmelCancerCenter.org

Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Other Identifiers

2005-58

Identifier Type: OTHER

Identifier Source: secondary_id

06C.46

Identifier Type: OTHER

Identifier Source: secondary_id

06C.46

Identifier Type: -

Identifier Source: org_study_id