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

Primary Purpose

Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Docetaxel
Bevacizumab
Erlotinib
Radiotherapy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and neck cancer, Parotid gland cancer, thyroid gland cancer, melanoma, Chemoradiotherapy, bevacizumab, erlotinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Complete Remission Rate
To obtain preliminary data on the complete remission rate for this treatment combination.

Full Information

First Posted
November 29, 2006
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00405405
Brief Title
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Official Title
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer, Melanoma, Stage IV Head and Neck Cancer
Keywords
Head and neck cancer, Parotid gland cancer, thyroid gland cancer, melanoma, Chemoradiotherapy, bevacizumab, erlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol, Platinol-AQ
Intervention Description
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Two cycles during neoadjuvant therapy Response assessment at approximately day 36 Concurrent biochemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Erlotinib hydrochloride, Tarceva
Intervention Description
Two cycles during neoadjuvant therapy (dose escalation) Response assessment at approximately day 36 Concurrent biochemoradiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiation therapy, Radiation oncology, XRT
Intervention Description
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
Primary Outcome Measure Information:
Title
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
Description
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
Time Frame
Day 36
Secondary Outcome Measure Information:
Title
Determination of Dose Limiting Toxicity (DTL)
Description
To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
Time Frame
30 days
Title
Complete Remission Rate
Description
To obtain preliminary data on the complete remission rate for this treatment combination.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pramila Rani Anne, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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