Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

NCT ID: NCT00513383

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

Determine the best dosing of panitumumab, chemotherapy and radiation.

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: 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

Carboplatin

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Intensity Modulated Radiation Therapy

Intervention Type: RADIATION

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

Part B

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

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: 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

Carboplatin

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Intensity Modulated Radiation Therapy

Intervention Type: RADIATION

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

5-Fluorouracil

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

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

Intervention Type: RADIATION

5-Fluorouracil

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

IMRT; 5-FU

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lori J. Wirth, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori J. Wirth, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

05-401

Identifier Type: -

Identifier Source: org_study_id