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CancerPhase 2NCT00446446

PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

A Phase 2 study testing Panitumumab in people with Cancer and Carcinoma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Carcinoma, Head and Neck Cancer
What is being tested?
Panitumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
30 Oct 2007to 29 Nov 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
  • Karnofsky Performance Status (KPS) score ≥ 60% at screening
  • Men or women age ≥18 years
  • Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Who cannot join

  • Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
  • Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
  • Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
  • History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
  • Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
  • Known allergy or hypersensitivity to any component of panitumumab
Show all 18Show fewer
  • Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:
  • Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
  • Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
  • Significant thromboembolic event ≤ 8 weeks prior to enrollment
  • Subjects not recovered from all previous acute radiotherapy-related toxicities
  • History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
  • History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
  • Subject is currently in a clinical trial ≤ 30 days prior to enrollment
  • Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
  • Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
  • Female subject who is pregnant or breast-feeding
  • Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.

About this study

Official title: Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).

Being tested
Panitumumab
Medical subject headings
Neoplasms, Carcinoma, Head and Neck Neoplasms, Neoplasm Metastasis, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanitumumabDrug

    Also called Vectibix

    Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.

Study groups in NCT00446446
Study groupRoleWhat they receive
PanitumumabExperimentalarticipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
Receives: Drug: Panitumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.

    Measured: From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).

Secondary outcomes (7)

  1. Time to Response

    Time to response was defined as the time from Study Day 1 to the first CR or PR that was subsequently confirmed.

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)

  2. Duration of Response

    Duration of response was defined as the time from first confirmed CR or PR to the earliest date of disease progression per a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Duration of response was analyzed using the Kaplan-Meier method.

    PD: At least a 20% increase in the size of target lesions, or an increase of 20% or greater of non-target lesions and the lesion(s) measure ≥ 10 mm in one dimension at the time of progression, or any new lesions.

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks)

  3. Rate of Disease Control

    Rate of disease control was defined as the percentage of participants with CR, PR, or stable disease (SD), as defined by a modified version of the RECIST criteria (version 1.0), prior to initiation of subsequent anti-cancer therapy.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of non-target lesions and no new lesions, or, if no target lesions were identified at screening, the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).

  4. Time to Progression

    Time to progression was defined as the time from Day 1 to the date of disease progression using a modified version of the RECIST criteria (version 1.0). Participants not meeting the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment. Time to progression was analyzed using the Kaplan-Meier method.

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).

  5. Progression Free Survival (PFS)

    PFS was defined as the time from Day 1 to the first date of disease progression, as defined by a modified version of the RECIST criteria (version 1.0), or death due to any cause (whichever comes first). Participants who were alive who did not meet the criteria for progression by the analysis data cut-off date were censored at the date of last evaluable disease assessment.

    PFS was analyzed using the Kaplan-Meier method.

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).

  6. Overall Survival (OS)

    Overall Survival was defined as the time from Day 1 to the date of death. For participants who did not die while on study, or were lost to follow-up, survival was censored at the end of study, or the date of last contact (whichever was first).

    Measured: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).

  7. Number of Participants With Adverse Events

    The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal) with the exception of some dermatology/skin AEs that were graded using the CTCAE v3.0 with modifications. Serious AEs include any event that was fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related adverse events (TRAEs) are those for which the investigator considered there to be a reasonable possibility that the event may have been caused by study drug.

    Measured: The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2007 (estimated)
  2. Study start30 Oct 2007
  3. Primary completion15 Dec 2010
  4. Study completion29 Nov 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446446
Sponsor's protocol ID
20062088
Status last verified
Sep 2022
First submitted
8 Mar 2007
Last updated
5 Oct 2022
Data monitoring committee
No

Publications

  • Rischin D, Spigel DR, Adkins D, Wein R, Arnold S, Singhal N, Lee O, Murugappan S. PRISM: Phase 2 trial with panitumumab monotherapy as second-line treatment in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Head Neck. 2016 Apr;38 Suppl 1:E1756-61. doi: 10.1002/hed.24311. Epub 2015 Dec 17.

    PubMed 26681429

  • Spigel D. Second-line panitumumab monotherapy for treatment of advanced head and neck cancer: the PRISM Trial. Community Oncology. 2008;5(Supp 11):1-4.

  • Kim TW, Elme A, Park JO, Udrea AA, Kim SY, Ahn JB, Valencia RV, Krishnan S, Manojlovic N, Guan X, Lofton-Day C, Jung AS, Vrdoljak E. Final Analysis of Outcomes and RAS/BRAF Status in a Randomized Phase 3 Study of Panitumumab and Best Supportive Care in Chemorefractory Wild Type KRAS Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2018 Sep;17(3):206-214. doi: 10.1016/j.clcc.2018.03.008. Epub 2018 Mar 21.

    PubMed 29703606

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab in people with Cancer and Carcinoma, 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 5 inclusion and 18 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 5 Oct 2022. 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 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 Mar 2016). 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?

Objective Response Rate (time frame: From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).). 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 NCT00446446, which also lists 3 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 5 Oct 2022.

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