Recurrent and/or Metastatic Head and Neck CancerPhase 3SPECTRUMNCT00460265
Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
A Phase 3 study testing ARM 2 and ARM 1 in people with Recurrent and/or Metastatic Head and Neck Cancer, run by Amgen.
Trial summary
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent and/or Metastatic Head and Neck Cancer
- What is being tested?
- ARM 2 and ARM 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- No sites listed yet
- Study dates
- May 2007to May 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman at least 18 years old.
- Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
- Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
- Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
- Measurable and non-measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- History or known presence of Central Nervous System (CNS) metastases.
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
- Nasopharyngeal carcinoma.
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
- Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
Show all 9Show fewer
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
- Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
- Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])
About this study
Official title: A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
- Being tested
- ARM 2, ARM 1
- Keywords
- Squamous Cell Carcinoma, Epidermal Growth Factor, Epidermal Growth Factor Receptor, SCCHN, Metastatic Head and Neck Cancer, EGFr, Head and Neck Cancer, Recurrent Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARM 2Drug
Subjects will receive Cisplatin plus 5FU
ARM 1Drug
Subjects will receive Panitumumab plus cisplatin and 5FU
| Study group | Role | What they receive |
|---|---|---|
| ARM 2 | Active comparator | Arm 2 consists of Cisplatin and 5-FU Receives: Drug: ARM 2 |
| ARM 1 | Experimental | ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU Receives: Drug: ARM 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from randomization to death
Measured: Upto 56 months
Secondary outcomes (5)
Overall Response Rate
An objective tumor response of complete or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 that was confirmed no less than 28 days after the criteria for response were first met. Complete response = disappearance of all target lesions and partial response = ≥30% reduction in lesion size.
Measured: Every 6 weeks until disease progression, up to 56 months
Duration of Response
Time from the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) to disease progression using a modified version of the RECIST v1.0 (see protocol Appendix H).
Measured: Every 6 weeks until disease progression, up to 56 months
Time to Progression
Time from randomization date to date of disease progression using a modified version of the RECIST 1.0 (see protocol Appendix H)
Measured: Every 6 weeks until disease progression, up to 56 months
Time to Response
Time from randomization date to the first confirmed objective response of complete or partial response (that is subsequently confirmed at least 28 days later) using a modified version of the RECIST v1.0.
Measured: Every 6 weeks until disease progression, upto 56 months
Progression Free Survival
Time from randomization date to date of disease progression using a modified version of the RECIST v1.0 or death.
Measured: Every 6 weeks until disease progression or deaths, upto 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent and/or Metastatic Head and Neck CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 658 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
- NCT00460265
- Sponsor's protocol ID
- 20050251
- Acronym
- SPECTRUM
- Status last verified
- Feb 2014
- First submitted
- 12 Apr 2007
- Last updated
- 7 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bach B, et al.SPECTRUM biomarkers HPV.Journal-004521;
Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.
PubMed 23746666
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- ClinicalTrials.gov ID
- NCT00460265
- Acronym / sponsor ID
- SPECTRUM / 20050251
- Keywords
- Squamous Cell Carcinoma, Epidermal Growth Factor, Epidermal Growth Factor Receptor, SCCHN, Metastatic Head and Neck Cancer, EGFr, Head and Neck Cancer, Recurrent Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Apr 2007 (estimated)
- Results
- Posted 14 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 2 | Active comparator | Drug: ARM 2Arm 2 consists of Cisplatin and 5-FU |
| ARM 1 | Experimental | Drug: ARM 1ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman at least 18 years old.
- Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
- Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
- Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
- Measurable and non-measurable disease.
Key exclusion criteria (9 listed)
- History or known presence of Central Nervous System (CNS) metastases.
- History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
- Nasopharyngeal carcinoma.
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
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 |
|---|---|---|
| ARM 2Subjects will receive Cisplatin plus 5FU | Drug | ARM 2 |
| ARM 1Subjects will receive Panitumumab plus cisplatin and 5FU | Drug | ARM 1 |
Primary outcome
Overall Survival
Time frame: Upto 56 months
Time from randomization to death
5 secondary outcomes
Overall Response Rate
Time frame: Every 6 weeks until disease progression, up to 56 months
Duration of Response
Time frame: Every 6 weeks until disease progression, up to 56 months
Time to Progression
Time frame: Every 6 weeks until disease progression, up to 56 months
Time to Response
Time frame: Every 6 weeks until disease progression, upto 56 months
Progression Free Survival
Time frame: Every 6 weeks until disease progression or deaths, upto 56 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBach B, et al.SPECTRUM biomarkers HPV.Journal-004521;
- Background: PubMed 23746666Vermorken JB, Stohlmacher-Williams J, Davidenko I, Licitra L, Winquist E, Villanueva C, Foa P, Rottey S, Skladowski K, Tahara M, Pai VR, Faivre S, Blajman CR, Forastiere AA, Stein BN, Oliner KS, Pan Z, Bach BA; SPECTRUM investigators. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697-710. doi: 10.1016/S1470-2045(13)70181-5. Epub 2013 Jun 6.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARM 2 and ARM 1 in people with Recurrent and/or Metastatic Head and Neck Cancer, run by Amgen.
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 6 inclusion and 9 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Jun 2011). 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?
Overall Survival (time frame: Upto 56 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 NCT00460265, which also lists 2 linked publications.
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 7 Mar 2014.