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"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"

Inclusion Criteria:

- Signed Inform Consent

- Age > 18 years

- Histologically or cytologically confirmed SCCHN

- Diagnosis of metastatic disease by the investigator and/or recurrent disease
determined to be incurable by surgery or radiotherapy

- Subjects who have received radiation as primary therapy are eligible if radiation
therapy treatment was completed > 4 weeks prior to inclusion

- Subjects who have previously received chemotherapy as part of the initial
multimodality treatment for locally advanced disease are eligible if the chemotherapy
was completed > 24 weeks prior to inclusion

- At least 1 unidimensionally measurable lesion of ≥ 20 mm using conventional
techniques or ≥10 mm with spiral CT scan. Target lesions must not be chosen from a
previously irradiated field unless there had been documented tumour progression in
that lesion prior to inclusion

- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at

- Haematological function:

- ANC ≥ 1.5 x 109 cells/L

- Hemoglobin ≥ 9.0 g/dL

- Platelet count ≥ 100 x 109/L

- Kidney function:

o Adequate renal function with creatinine clearance ≥ 60 mL/min)

- Liver function:

- AST ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)

- ALT ≤ 3 x ULN (if liver metastases, ≤ 5 x ULN)

- Bilirubin ≤ 2 x ULN

- Metabolic function:

- Magnesium ≥ lower limit of normal,

- Calcium ≥ lower limit of normal

Exclusion Criteria:

- Documented or symptomatic central nervous system metastases

- Nasopharyngeal carcinoma

- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest scan

- History of another primary cancer, except:

- Curatively treated in situ cervical cancer, or

- Curatively resected non-melanoma skin cancer or

- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for ≥ 3 years prior to starting the study
treatment. In that case confirmation of inclusion by the sponsor is required.

- Clinically significant cardiovascular disease ≤ 1 year prior to starting the study

- Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
8 weeks prior to starting the study treatment

- Symptomatic peripheral neuropathy of Grade ≥ 2 based on the CTCAE v3.0

- Subjects not recovered from all previous acute radiotherapy-related toxicities to ≤
grade 1

- History of severe skin disorder that in the opinion of the investigator may interfere
with study conduct

- Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
virus, acute or chronic hepatitis B infection

- Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days
prior to starting the study treatment

- History of interstitial pneumonia or pulmonary fibrosis or signs of interstitial
pneumonia or pulmonary fibrosis on the baseline chest X-ray.

- Known allergy or hypersensitivity to panitumumab, or other study medications.

- Prior anti epidermal growth factor receptor (EGFr) antibody therapy or treatment with
small molecule EGFr inhibitors unless received as part of prior multimodality
treatment and completed > 24 weeks prior to starting the study treatment. In this
case, the investigator should confirm that the subject had not presented any previous
cetuximab-related infusion reaction > grade 2.

- Subject is currently enrolled in or ≤ 30 days since ending other investigational
device, investigational procedure, or drug study(s), or subject is receiving other
investigational agent(s)

- Subjects requiring use of immunosuppressive agents, however, corticosteroids are

- Man or woman of child-bearing potential who do not consent to use adequate
contraceptive precautions during the course of the study, and for 6 months after the
last study drug administration for women, and 3 months for men.

- Female subject who is pregnant or breast-feeding, or planning to become pregnant
within 6 months after the end of treatment.

- Major surgery requiring general anesthesia/ spinal anesthesia and a significant
incision ≤ 28 days or minor surgery ≤ 14 days prior to starting the study treatment.
Subjects must have recovered from surgery-related toxicities.

- Subjects who do not wish to meet the study requirements or are unable to do so.

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Description:

To assess the effect of the combination of panitumumab and paclitaxel on objective response rate in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Juan Jesús Cruz Hernández, Professor

Investigator Role:

Study Director

Investigator Affiliation:

Hospital Universitario de Salamanca


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

December 2010

Completion Date:

October 2012

Related Keywords:

  • Head and Neck Cancer
  • Head and neck cancer, panitumumab, TTCC-2009-03
  • Head and Neck Neoplasms