Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

NCT00513383 | Completed Phase 1 DMC

• 1 other identifier: 05-401
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to test whether panitumumab, in combination with chemotherapy and radiation is safe in people with head and neck cancer. Another goal of this study is to find the highest dose of the study drugs that can be given safely without causing serious sife effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in other types of cancers, such as kidney and colon. This monoclonal antibody is directed against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth of head and neck cancer cells.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

basaloid squamous cell carcinoma; undifferentiated carcinoma; adenosquamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

• To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy.

  2 years

• To identify the maximally tolerated dose or biologically acceptable dose of TPF, varying the 5-FU dose, given with a fixed dose of panitumumab, prior to concurrent carboplatin, paclitaxel, panitumumab chemoradiotherapy.

  2 years

Secondary Outcomes (5)

• To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF.

  2 years

• To estimate the overall response rate to Pan-TPF.

  2 years

• To estimate the overall response rate of sequential therapy.

  2 years

• To estimate the rate of pathologic complete response of primary tumor biopsy, to estimate 2-year disease free survival and overall survival.

• To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life.

  2 years

Study Arms (2)

Part A

EXPERIMENTAL

Determine the best dosing of panitumumab, chemotherapy and radiation.

Drug: Panitumumab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Intensity Modulated Radiation Therapy

Part B

EXPERIMENTAL

Determine the best dosing of induction chemotherapy combined with panitumumab prior to receiving panitumumab and chemoradiotherapy.

Drug: Panitumumab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Intensity Modulated Radiation Therapy; Drug: 5-Fluorouracil; Drug: Docetaxel; Drug: Cisplatin

Interventions

Panitumumab DRUG

Part A: Intravenously once a week for 7 weeks Part B (Induction Chemotherapy): Intravenously on Day 1 of a 21-day cycle for 3 cycles Part B (After Induction chemotherapy): Intravenously once a week for 7 weeks at the dosing level established during Part A

Part A; Part B

Carboplatin DRUG

Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks

Part A; Part B

Paclitaxel DRUG

Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks

Part A; Part B

Intensity Modulated Radiation Therapy RADIATION

Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks

Also known as: IMRT

Part A; Part B

5-Fluorouracil DRUG

Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles

Also known as: 5-FU

Part B

Docetaxel DRUG

Intravenously on day 1 of a 21-day cycle for 3 cycles

Part B

Cisplatin DRUG

Intravenously on day 1 of a 21-day cycle for 3 cycles

Part B

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven squamous cell carcinoma of the head and neck or its variants (such as basaloid squamous cell carcinoma, undifferentiated carcinoma, or adenosquamous cell carcinoma). Primary tumor sites eligible include: nasopharynx, oral cavity, oropharynx, hypopharynx, larynx or unknown primary SCCHN
• Stage III or IV disease, without evidence of distant metastasis, according to American Joint Committee on Cancer
• Measurable disease, according to RECIST.
• No prior chemotherapy, radiotherapy or attempted complete resection of the SCCHN. Diagnostic biopsy, including excisional nodal biopsy and/or tonsillectomy is allowed if the subject has measurable disease at the time of enrollment
• years of age or older
• ECOG Performance Status of 0 or 1
• No active alcohol addiction or other condition that, in the opinion of the study investigators, would interfere with the subject's ability to comply with the treatment plan
• Adequate hepatic and renal function
• Women of childbearing potential must have a negative pregnancy test within 2 weeks of study entry.

You may not qualify if:

• Pregnant or breast feeding women
• Symptomatic peripheral neuropathy of grade 2 or higher by NCI CTCAEv3.0
• Grade 3 or more hearing loss
• History of other malignancy within the previous 5 years, except for nonmelanoma skin cancer, carcinoma in situ of the cervix, bladder or head and neck
• Prior radiation to head and neck
• Other serious illness or medical conditions
• Patients who experienced an involuntary weight loss of more than 20% of their body weight in the 2 months preceding study entry
• Concurrent treatment with any other anticancer therapy
• Prior therapy which affects or targets the ErbB pathway, including any inhibitors of EGFR and ErbB2
• Participation in an investigational drug trial within 30 days of study entry

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Amgen: collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Wirth, L.J. Phase I Study of Panitumumab, Chemotherapy, and Intensity-modulated Radiotherapy (IMRT) for head and neck cancer (HNC). Abstract-No.6083 2007 ASCO Annual Meeting

  BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Adenosquamous

Interventions

Panitumumab; Carboplatin; Paclitaxel; Radiotherapy, Intensity-Modulated; Fluorouracil; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Complex and Mixed

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Lori J. Wirth, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: April 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2012
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (2)