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Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Panitumumab

Carboplatin

Paclitaxel

Intensity Modulated Radiation Therapy

5-Fluorouracil

Docetaxel

Cisplatin

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring basaloid squamous cell carcinoma, undifferentiated carcinoma, adenosquamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute
Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A

Part B

Arm Description

Determine the best dosing of panitumumab, chemotherapy and radiation.

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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

To estimate the overall response rate to Pan-TPF.

To estimate the overall response rate of sequential therapy.

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.

Full Information

NCT ID

NCT00513383

First Posted

August 7, 2007

Last Updated

February 27, 2017

Sponsor

Massachusetts General Hospital

Collaborators

Brigham and Women's Hospital, Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00513383

Brief Title

Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

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 Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Brigham and Women's Hospital, Amgen

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Head and Neck

Keywords

basaloid squamous cell carcinoma, undifferentiated carcinoma, adenosquamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A

Arm Type

Experimental

Arm Description

Determine the best dosing of panitumumab, chemotherapy and radiation.

Arm Title

Part B

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Panitumumab

Intervention Description

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

Intervention Name(s)

Carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Intensity Modulated Radiation Therapy

Other Intervention Name(s)

IMRT

Intervention Description

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

Drug

Intervention Name(s)

5-Fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

To estimate the overall response rate to Pan-TPF.

Time Frame

2 years

Title

To estimate the overall response rate of sequential therapy.

Time Frame

2 years

Title

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

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lori J. Wirth, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

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Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

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