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

October 19, 2016 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
Drug: Cisplatin
  • Two cycles during neoadjuvant therapy
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
  • cisplatinum
  • cis-diamminedichloroplatinum(II)
Drug: Docetaxel
  • Two cycles during neoadjuvant therapy
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Names:
  • Taxotere
Drug: Bevacizumab
  • Two cycles during neoadjuvant therapy
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Names:
  • Avastin
Drug: Erlotinib
  • Two cycles during neoadjuvant therapy (dose escalation)
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Names:
  • Tarceva
  • Erlotinib hydrochloride
Radiation: Radiotherapy
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
Other Names:
  • Radiation therapy
  • XRT
  • Radiation oncology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
Time Frame: Day 36
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
Day 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Dose Limiting Toxicity (DTL)
Time Frame: 30 days
To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
30 days
Complete Remission Rate
Time Frame: 6 months
To obtain preliminary data on the complete remission rate for this treatment combination.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Pramila Rani Anne, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06C.46
  • 2005-58 (Other Identifier: CCRRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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