Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and neck cancer, panitumumab, TTCC-2009-03
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Panitumumab + paclitaxel
Type: Drug
Overall Status
Not yet recruiting
Summary
The clinical hypothesis of this study is that the first-line treatment with the combination of panitumumab and paclitaxel will provide benefit for patients with metastatic or current Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 screening

- 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 treatment

- 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 allowed

- 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.
Location
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Salamanca, Spain
Status: Not yet recruiting
Start Date
December 2010
Completion Date
October 2012
Sponsors
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Source
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page