Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck - Full Text View

Purpose

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.

Condition	Intervention	Phase
Squamous Cell Carcinoma of the Head and Neck	Drug: Panitumumab Drug: Carboplatin Drug: Paclitaxel Radiation: Intensity Modulated Radiation Therapy Drug: 5-Fluorouracil Drug: Docetaxel Drug: Cisplatin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Fluorouracil Cisplatin Paclitaxel Carboplatin Docetaxel Panitumumab

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To estimate the overall response rate to Pan-TPF. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To estimate the overall response rate of sequential therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To estimate the rate of pathologic complete response of primary tumor biopsy, to estimate 2-year disease free survival and overall survival. [ Time Frame: TBD ] [ Designated as safety issue: No ]
To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part A Determine the best dosing of panitumumab, chemotherapy and radiation.	Drug: Panitumumab 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 Drug: Carboplatin Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks Drug: Paclitaxel Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks Radiation: Intensity Modulated Radiation Therapy Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks Other Name: IMRT
Experimental: Part B Determine the best dosing of induction chemotherapy combined with panitumumab prior to receiving panitumumab and chemoradiotherapy.	Drug: Panitumumab 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 Drug: Carboplatin Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks Drug: Paclitaxel Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks Radiation: Intensity Modulated Radiation Therapy Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks Other Name: IMRT Drug: 5-Fluorouracil Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles Other Name: 5-FU Drug: Docetaxel Intravenously on day 1 of a 21-day cycle for 3 cycles Drug: Cisplatin Intravenously on day 1 of a 21-day cycle for 3 cycles

Arms

Assigned Interventions

Experimental: Part A

Determine the best dosing of panitumumab, chemotherapy and radiation.

Drug: Panitumumab

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

Drug: Carboplatin

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

Drug: Paclitaxel

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

Radiation: Intensity Modulated Radiation Therapy

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

Other Name: IMRT

Experimental: Part B

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

Drug: Panitumumab

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

Drug: Carboplatin

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

Drug: Paclitaxel

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

Radiation: Intensity Modulated Radiation Therapy

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

Other Name: IMRT

Drug: 5-Fluorouracil

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

Other Name: 5-FU

Drug: Docetaxel

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

Drug: Cisplatin

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

Detailed Description:

There are two parts to this study: Part A and Part B. Participants enrolled in Part A of this study received panitumumab and chemoradiotherapy. Participants enrolled in Part B will receive panitumumab in combination with induction chemotherapy followed by chemoradiotherapy.
The main purpose of Part A was to examine the safety and the best dosing of panitumumab, chemotherapy and radiation for the treatment of head and neck cancer. The best dosing was determined by increasing doses of chemotherapy given in combination with panitumumab during radiation. The chemotherapy drugs being used in Part A were carboplatin and paclitaxel, which are standard therapies used in head and neck cancer. These drugs were be added to radiation and this combination is called chemoradiotherapy. The investigators have determined the best dose of panitumumab and chemotherapy to give with radiation, Part B has now begun.
The main purpose of Part B is to examine the safety and best dosing of chemotherapy combined with panitumumab (called induction therapy) prior to receiving panitumumab and chemoradiotherapy. The drugs that are used for induction chemotherapy will be docetaxel, cisplatin and 5-fluorouracil. These drugs are also standard therapies used in head and neck cancer.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
18 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513383

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

Brigham and Women's Hospital

Amgen

Investigators

Principal Investigator:

Lori J. Wirth, MD

Massachusetts General Hospital

More Information

Publications:

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

Responsible Party:	Lori J. Wirth, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00513383 History of Changes
Other Study ID Numbers:	05-401
Study First Received:	August 7, 2007
Last Updated:	March 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

basaloid squamous cell carcinoma
undifferentiated carcinoma
adenosquamous cell carcinoma

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Carboplatin
Paclitaxel
Antibodies, Monoclonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013