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

Head and Neck Cancer Clinical Trial

Official title:

A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405405
• Other study ID #: 06C.46
• Secondary ID: 2005-58
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2006
• Last updated: October 19, 2016
• Start date: December 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Melanoma
• Parotid Gland Cancer
• Parotid Neoplasms
• Stage IV Head and Neck Cancer
• Thyroid Gland Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Cisplatin
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
• Docetaxel
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
• Bevacizumab
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
• Erlotinib
Two cycles during neoadjuvant therapy (dose escalation) Response assessment at approximately day 36 Concurrent biochemoradiotherapy

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer	To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.	Day 36	Yes
Secondary	Determination of Dose Limiting Toxicity (DTL)	To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.	30 days	Yes
Secondary	Complete Remission Rate	To obtain preliminary data on the complete remission rate for this treatment combination.	6 months	No

External Links

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