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

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ClinicalTrials.gov Identifier: NCT00405405
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 21, 2016
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Parotid Gland Cancer Thyroid Gland Cancer Melanoma Stage IV Head and Neck Cancer Drug: Cisplatin Drug: Docetaxel Drug: Bevacizumab Drug: Erlotinib Radiation: Radiotherapy Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
Study Start Date : December 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010


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:
  • cisplatinum
  • cis-diamminedichloroplatinum(II)
  • CDDP
  • Platinol
  • Platinol-AQ

Drug: Docetaxel
  • Two cycles during neoadjuvant therapy
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Name: Taxotere

Drug: Bevacizumab
  • Two cycles during neoadjuvant therapy
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Name: Avastin

Drug: Erlotinib
  • Two cycles during neoadjuvant therapy (dose escalation)
  • Response assessment at approximately day 36
  • Concurrent biochemoradiotherapy
Other Names:
  • Erlotinib hydrochloride
  • Tarceva

Radiation: Radiotherapy
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
Other Names:
  • Radiation therapy
  • Radiation oncology
  • XRT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Complete Remission Rate [ Time Frame: 6 months ]
    To obtain preliminary data on the complete remission rate for this treatment combination.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405405


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Genentech, Inc.
Investigators
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Principal Investigator: Pramila Rani Anne, MD Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00405405     History of Changes
Other Study ID Numbers: 06C.46
2005-58 ( Other Identifier: CCRRC )
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Head and neck cancer
Parotid gland cancer
thyroid gland cancer
melanoma
Chemoradiotherapy
bevacizumab
erlotinib

Additional relevant MeSH terms:
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Melanoma
Head and Neck Neoplasms
Parotid Neoplasms
Thyroid Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Salivary Gland Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Cisplatin
Bevacizumab
Docetaxel
Erlotinib Hydrochloride
Antineoplastic Agents
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances