Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer, Carcinoma, Head and Neck Cancer, Metastases, Metastatic Cancer, Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck, Oncology, Squamous Cell Carcinoma, Tumors

Thank you

Trial Information

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


Inclusion Criteria:



- 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 CT or 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

Exclusion Criteria:

- 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

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

70 days

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20062088

NCT ID:

NCT00446446

Start Date:

May 2007

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • Carcinoma
  • Head and Neck Cancer
  • Metastases
  • Metastatic Cancer
  • Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
  • Oncology
  • Squamous Cell Carcinoma
  • Tumors
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location