Metastatic or Recurrent Squamous Cell Carcinoma of Head and NeckPhase 2NCT00454779
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
A Phase 2 study testing Cisplatin, Panitumumab and Docetaxel in people with Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck, run by Amgen at 114 sites in 9 countries.
Trial summary
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Cisplatin, Panitumumab and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 114 sitesin 9 countries
- Study dates
- 1 Jan 2007to 1 Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
- Measurable disease by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Age: 18 years or older
- Adequate hematologic, renal, metabolic, hepatic \& thyroid function
Who cannot join
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- CNS metastases, or nasopharyngeal carcinoma
- History of interstitial lung disease
- History of another primary cancer
- Any co-morbid disease that would increase risk of toxicity
- Active infection requiring systemic treatment
- Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
Trial locations and contacts
114 sites in 9 countries.
114 sites in 9 countries
United States82 sites
Research Site
Abingdon, Virginia, 24211
Research Site
Ann Arbor, Michigan, 48106-0995
Research Site
Arlington, Texas, 76012
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Ashland, Kentucky, 41101
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Athens, Georgia, 30607
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Aurora, Colorado, 80045
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Baltimore, Maryland, 21204
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Baltimore, Maryland, 21237
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Billings, Montana, 59102
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Binghamton, New York, 13905
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Boston, Massachusetts, 02114
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Canton, Ohio, 44718
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Centralia, Illinois, 62801
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Charleston, South Carolina, 29406
Research Site
Charleston, South Carolina, 29425
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Chesapeake, Virginia, 23320
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Cincinnati, Ohio, 45236
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Columbia, Missouri, 65201
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Corpus Christi, Texas, 78405
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Corpus Christi, Texas, 78412
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Dallas, Texas, 75201
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Dallas, Texas, 75230
Research Site
Dallas, Texas, 75234
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Dayton, Ohio, 45420
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Denver, Colorado, 80210
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Duarte, California, 91010
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Elk Grove Village, Illinois, 60007
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Evanston, Illinois, 60201
Research Site
Frederick, Maryland, 21701
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Galveston, Texas, 77555-0158
Research Site
Greenville, South Carolina, 29615
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Griffin, Georgia, 30224
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Hackensack, New Jersey, 07601
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Henderson, Nevada, 59074
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Jefferson City, Missouri, 65109
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Jonesboro, Arkansas, 72401
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La Jolla, California, 92037
Research Site
La Verne, California, 91750
Research Site
Lakeland, Florida, 33805
Research Site
Langhorne, Pennsylvania, 19047
Research Site
Lansing, Michigan, 48910
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Lexington, Kentucky, 40536
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202-1703
Research Site
Louisville, Kentucky, 40202
Research Site
Madison, Wisconsin, 53792
Research Site
Marietta, Georgia, 30060
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Marshfield, Wisconsin, 54449
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Memphis, Tennessee, 38120
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Miami, Florida, 33176
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Mineola, New York, 11501
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Morgantown, West Virginia, 26506
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New Port Richey, Florida, 34655
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New York, New York, 10003
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New York, New York, 10032
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Newark, Delaware, 19713
Research Site
Norwich, Connecticut, 06360
Research Site
Nyack, New York, 10960
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Omaha, Nebraska, 68114
Research Site
Orlando, Florida, 32806
Research Site
Paducah, Kentucky, 42003
Research Site
Park Ridge, Illinois, 60068
Research Site
Pascagoula, Mississippi, 39581
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Rochester, New York, 14623
Research Site
San Antonio, Texas, 78229
Research Site
Santa Cruz, California, 95065
Research Site
Scranton, Pennsylvania, 18510
Research Site
St Louis, Missouri, 63110-1093
Research Site
St Louis, Missouri, 63110
Research Site
Syracuse, New York, 13210
Research Site
The Bronx, New York, 10457
Research Site
The Bronx, New York, 10467
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Toledo, Ohio, 43614
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Tucson, Arizona, 85715
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Washington D.C., District of Columbia, 20007
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Washington D.C., District of Columbia, 20010
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Washington D.C., District of Columbia, 20037
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Washington D.C., District of Columbia, 20422
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Wichita, Kansas, 67214
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Zion, Illinois, 60099
Belgium7 sites
Research Site
Brasschaat, 2930
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Bruges, 8000
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Kortrijk, 8500
Research Site
Libramont, 6800
Research Site
Liège, 4000
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Ottignies, 1340
Research Site
Wilrijk, 2610
Spain6 sites
Research Site
Barcelona, Catalonia, 08025
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Girona, Catalonia, 17007
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L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
Madrid, 28040
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Santander, Cantabria, 39008
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Valencia, Valencia, 46009
Slovakia5 sites
Research Site
Banská Bystrica, 974 01
Research Site
Bratislava, 812 50
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Nové Zámky, 940 34
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Prešov, 080 01
Research Site
Spišská Nová Ves, 052 01
Austria4 sites
Research Site
Graz, 8036
Research Site
Leoben, 8700
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Linz, 4010
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Vienna, 1090
France4 sites
Research Site
Angers, 49933
Research Site
Lens, 62307
Research Site
Perpignan, 66000
Research Site
Vandœuvre-lès-Nancy, 54511
Czechia3 sites
Research Site
Brno, 656 53
Research Site
Prague, 150 06
Research Site
Znojmo, 669 02
About this study
Official title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
- Keywords
- SCCHNC, Metastatic, Recurrent
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
chemotherapy arm
PanitumumabDrug
experimental arm
DocetaxelDrug
chemotherapy arm
CisplatinDrug
experimental arm
DocetaxelDrug
experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Panitumumab + Docetaxel + Cisplatin Receives: Drug: Panitumumab; Drug: Cisplatin; Drug: Docetaxel |
| Arm 2 | Other | control Receives: Drug: Cisplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) During the First-line Treatment Phase
The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.
Measured: Every 6 weeks until disease progression or death, up to 67 months
Secondary outcomes (11)
Overall Response Rate (ORR) During the First-line Treatment Phase
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
Measured: Every 6 weeks until disease progression or death, up to 67 months
Rate of Disease Control (RDC) During the First-line Treatment Phase
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
Measured: Every 6 weeks until disease progression or death, up to 67 months
Duration of Response (DOR) During the First-line Treatment Phase
Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Measured: Every 6 weeks until disease progression or death, up to 67 months
Time to Response (TTR) During the First-line Treatment Phase
Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter)
Measured: Every 6 weeks until disease progression or death, up to 67 months
Overall Survival (OS) for the First-line Treatment
Time from the date of randomization to the date of death during the entire study
Measured: Until death, up to 67 months
Progression Free Survival (PFS) During the Second-line Treatment Phase
The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase.
Measured: Every 6 weeks until disease progression or death, up to 57 months
Overall Response Rate (ORR) During the Second-line Treatment Phase
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population.
Measured: Every 6 weeks until disease progression or death, up to 57 months
Rate of Disease Control (RDC) During the Second-line Treatment Phase
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), >=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population.
Measured: Every 6 weeks until disease progression or death, up to 57 months
Duration of Response (DOR) During the Second-line Treatment Phase
Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Measured: Every 6 weeks until disease progression or death, up to 57 months
Time to Response (TTR) During the Second-line Treatment Phase
Time from the first dose of panitumumab monotherapy to the first CR or PR during second-line treatment phase (subsequently confirmed at least 4 weeks thereafter)
Measured: Every 6 weeks until disease progression or death, up to 57 months
Overall Survival (OS) for the Second-line Treatment
Time from the first dose of panitumumab monotherapy to the date of death during the entire study
Measured: Until death, up to 57 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study start1 Jan 2007
- Primary completion11 Jun 2012
- Study completion1 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic or Recurrent Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454779
- Sponsor's protocol ID
- 20050236
- Status last verified
- Sep 2018
- First submitted
- 29 Mar 2007
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
- ClinicalTrials.gov ID
- NCT00454779
- Acronym / sponsor ID
- 20050236
- Keywords
- SCCHNC, Metastatic, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 11 Jun 2012 (actual)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Posted 7 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Panitumumab, Drug: Cisplatin, Drug: DocetaxelPanitumumab + Docetaxel + Cisplatin |
| Arm 2 | Other | Drug: Cisplatin, Drug: Docetaxelcontrol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
- Measurable disease by CT scan
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Age: 18 years or older
- Adequate hematologic, renal, metabolic, hepatic \& thyroid function
Key exclusion criteria (7 listed)
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- CNS metastases, or nasopharyngeal carcinoma
- History of interstitial lung disease
- History of another primary cancer
- Any co-morbid disease that would increase risk of toxicity
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 |
|---|---|---|
| Cisplatinchemotherapy arm | Drug | Arm 2 |
| Panitumumabexperimental arm | Drug | Arm 1 |
| Docetaxelchemotherapy arm | Drug | Arm 2 |
| Cisplatinexperimental arm | Drug | Arm 1 |
| Docetaxelexperimental arm | Drug | Arm 1 |
Primary outcome
Progression Free Survival (PFS) During the First-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 67 months
The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.
11 secondary outcomes
Overall Response Rate (ORR) During the First-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 67 months
Rate of Disease Control (RDC) During the First-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 67 months
Duration of Response (DOR) During the First-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 67 months
Time to Response (TTR) During the First-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 67 months
Overall Survival (OS) for the First-line Treatment
Time frame: Until death, up to 67 months
Progression Free Survival (PFS) During the Second-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 57 months
Overall Response Rate (ORR) During the Second-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 57 months
Rate of Disease Control (RDC) During the Second-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 57 months
Duration of Response (DOR) During the Second-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 57 months
Time to Response (TTR) During the Second-line Treatment Phase
Time frame: Every 6 weeks until disease progression or death, up to 57 months
Overall Survival (OS) for the Second-line Treatment
Time frame: Until death, up to 57 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
114 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Panitumumab and Docetaxel in people with Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck, run by Amgen at 114 sites in 9 countries.
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 5 inclusion and 7 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 114 sites in United States, Belgium, Spain, Slovakia, Austria and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) During the First-line Treatment Phase (time frame: Every 6 weeks until disease progression or death, up to 67 months). 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 NCT00454779, 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 17 Oct 2018.