Squamous Cell Carcinoma of the Head and NeckPhase 1NCT00513383
Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck
A Phase 1 study testing Panitumumab, Carboplatin and Paclitaxel in people with Squamous Cell Carcinoma of the Head and Neck, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Panitumumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
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.
Read the 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.
- Being tested
- Panitumumab, Carboplatin, Paclitaxel, Intensity Modulated Radiation Therapy, 5-Fluorouracil
- Keywords
- basaloid squamous cell carcinoma, undifferentiated carcinoma, adenosquamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Carcinoma, Adenosquamous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
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
CarboplatinDrug
Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
PaclitaxelDrug
Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks
5-FluorouracilDrug
Also called 5-FU
Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles
DocetaxelDrug
Intravenously on day 1 of a 21-day cycle for 3 cycles
CisplatinDrug
Intravenously on day 1 of a 21-day cycle for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Determine the best dosing of panitumumab, chemotherapy and radiation. Receives: 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. Receives: Drug: Panitumumab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Intensity Modulated Radiation Therapy; Drug: 5-Fluorouracil; Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy.
Measured: 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.
Measured: 2 years
Secondary outcomes (5)
To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF.
Measured: 2 years
To estimate the overall response rate to Pan-TPF.
Measured: 2 years
To estimate the overall response rate of sequential therapy.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2010
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Amgen
- Responsible party
- Principal investigator, Lori J. Wirth, MD, Massachusetts General Hospital
- Investigators
- Lori J. Wirth, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513383
- Sponsor's protocol ID
- 05-401
- Status last verified
- Feb 2017
- First submitted
- 7 Aug 2007
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
- ClinicalTrials.gov ID
- NCT00513383
- Acronym / sponsor ID
- 05-401
- Keywords
- basaloid squamous cell carcinoma, undifferentiated carcinoma, adenosquamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Amgen
- Study start
- Apr 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Panitumumab, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Intensity Modulated Radiation TherapyDetermine the best dosing of panitumumab, chemotherapy and radiation. |
| Part B | Experimental | Drug: Panitumumab, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Intensity Modulated Radiation Therapy, Drug: 5-Fluorouracil, Drug: Docetaxel, Drug: CisplatinDetermine the best dosing of induction chemotherapy combined with panitumumab prior to receiving panitumumab and chemoradiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PanitumumabPart 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 | Part A, Part B |
| CarboplatinPart A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks | Drug | Part A, Part B |
| PaclitaxelPart A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks | Drug | Part A, Part B |
| Intensity Modulated Radiation TherapyAlso: IMRTPart A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks | Radiation | Part A, Part B |
| 5-FluorouracilAlso: 5-FUIntravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles | Drug | Part B |
| DocetaxelIntravenously on day 1 of a 21-day cycle for 3 cycles | Drug | Part B |
| CisplatinIntravenously on day 1 of a 21-day cycle for 3 cycles | Drug | Part B |
Primary outcome
To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy.
Time frame: 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.
Time frame: 2 years
5 secondary outcomes
To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF.
Time frame: 2 years
To estimate the overall response rate to Pan-TPF.
Time frame: 2 years
To estimate the overall response rate of sequential therapy.
Time frame: 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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- BackgroundWirth, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori J. Wirth, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Panitumumab, Carboplatin and Paclitaxel in people with Squamous Cell Carcinoma of the Head and Neck, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.