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

NCT00446446 | Completed Phase 2 Results

• 1 other identifier: 20062088
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Cancer; Carcinoma; Head and Neck Cancer; Metastases; Metastatic Cancer; Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck; Oncology; Squamous Cell Carcinoma; Tumors

Outcome Measures

Primary Outcomes (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.

  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)

• Time to Response

  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)

• Duration of Response

  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)

• Rate of Disease Control

  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).

• Time to Progression

  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).

• Progression Free Survival (PFS)

  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).

Study Arms (1)

Panitumumab

EXPERIMENTAL

articipants 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.

Drug: Panitumumab

Interventions

Panitumumab DRUG

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

Also known as: Vectibix

Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• 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.

  PMID: 26681429 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29703606 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Carcinoma; Head and Neck Neoplasms; Neoplasm Metastasis; Carcinoma, Squamous Cell

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 12, 2007
• Study Start: October 30, 2007
• Primary Completion: December 15, 2010
• Study Completion: November 29, 2017
• Last Updated: October 5, 2022
• Results First Posted: March 7, 2016

Record last verified: 2022-09