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

NCT00405405 | Completed Phase 1 DMC

• 2 other identifiers: 06C.462005-58
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Determination of Dose Limiting Toxicity (DTL)

  30 days

• Complete Remission Rate

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Cisplatin; Drug: Docetaxel; Drug: Bevacizumab; Drug: Erlotinib; Radiation: Radiotherapy

Interventions

Cisplatin DRUG

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

Also known as: cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol, Platinol-AQ

Treatment

Docetaxel DRUG

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

Also known as: Taxotere

Treatment

Bevacizumab DRUG

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

Also known as: Avastin

Treatment

Erlotinib DRUG

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

Also known as: Erlotinib hydrochloride, Tarceva

Treatment

Radiotherapy RADIATION

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

Also known as: Radiation therapy, Radiation oncology, XRT

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms; Parotid Neoplasms; Thyroid Neoplasms; Melanoma

Interventions

Cisplatin; Docetaxel; Bevacizumab; Erlotinib Hydrochloride; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Physical Phenomena

Study Officials

• Pramila Rani Anne, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)