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Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

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ClinicalTrials.gov Identifier: NCT00513383
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2006
Primary Completion Date : October 2010
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy. [ Time Frame: 2 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF. [ Time Frame: 2 years ]
  2. To estimate the overall response rate to Pan-TPF. [ Time Frame: 2 years ]
  3. To estimate the overall response rate of sequential therapy. [ Time Frame: 2 years ]
  4. To estimate the rate of pathologic complete response of primary tumor biopsy, to estimate 2-year disease free survival and overall survival.
  5. To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Lori J. Wirth, MD, Massachusetts General Hospital:
basaloid squamous cell carcinoma
undifferentiated carcinoma
adenosquamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Carboplatin
Fluorouracil
Antibodies, Monoclonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs