Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer (VECTITAX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Amgen
Trial Form Support S.L.
Information provided by:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier:
NCT01264328
First received: December 2, 2010
Last updated: December 20, 2010
Last verified: April 2010
  Purpose

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)


Condition Intervention Phase
Head and Neck Cancer
Drug: Panitumumab + paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"

Resource links provided by NLM:


Further study details as provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:

Primary Outcome Measures:
  • objective response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time to response, duration of response, progression free-survival, overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    Secondary Objectives

    • To assess the disease control rate, time to response, duration of response, progression free-survival and overall survival.
    • To estimate changes in patient-reported outcomes (PRO).
    • To describe the safety profile of the combination of panitumumab and paclitaxel.

    1.3 Exploratory Objectives:

    • To investigate the effects of genetic variation in cancer genes and drug target genes on subject response to panitumumab and Paclitaxel combination chemotherapy.
    • To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab + Paclitaxel Drug: Panitumumab + paclitaxel
Paclitaxel 80 mg/m2 may be infused, intravenously, over one hour every week. Panitumumab will be administered every 2 weeks at a dose of 6 mg/kg, using a non pyrogenic low protein binding filter with a 0.20-0.22-μm pore size intravenously over 1 hour ± 15 minutes. Panitumumab will be administered prior to paclitaxel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264328

Contacts
Contact: Juan Carlos Adansa, MD unidad_eecc@usal.es
Contact: Elisabet Molina elisabet.molina@trialformsupport.com

Locations
Spain
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello Not yet recruiting
Salamanca, Spain
Principal Investigator: Elvira del Barco, MD         
Sponsors and Collaborators
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Amgen
Trial Form Support S.L.
Investigators
Study Director: Juan Jesús Cruz Hernández, Professor Hospital Universitario de Salamanca
Principal Investigator: Javier Martínez, MD Hospital Miguel Servet de Zaragoza
Principal Investigator: Juan José Grau, MD Hospital Clínic i Provincial de Barcelona
Principal Investigator: Joaquina Martínez, MD Hospital Virgen de las Nieves Granada
Principal Investigator: Antonio López Pousa, MD Hospital de la Santa Creu i Sant Pau de Barcelona
Principal Investigator: Alfonso Berrocal, MD Hospital General Universitario de Valencia
Principal Investigator: Ricardo Hitt, MD Hospital 12 de Octubre de Madrid
Principal Investigator: Ricardo Mesia, MD Institut Català d'Oncología. Hospital Duran i Reynals de Barcelona
Study Director: Elvira del Barco, MD Hospital Universitario de Salamanca
Principal Investigator: Carlos García, MD Hospital General Yagüe de Burgos
Principal Investigator: Alicia Hurtado, MD Fundación Hospitalaria de Alcorcón de Madrid
Principal Investigator: Miguel Pastor, MD Hospital La Fe de Valencia
Principal Investigator: Ruth Vera, MD Hospital de Navarra
  More Information

No publications provided

Responsible Party: Dr. Juan Carlos Adansa, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
ClinicalTrials.gov Identifier: NCT01264328     History of Changes
Other Study ID Numbers: TTCC-2009-03
Study First Received: December 2, 2010
Last Updated: December 20, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello:
Head and neck cancer, panitumumab, TTCC-2009-03

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014