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

NCT01264328 | Completed Phase 2

• 1 other identifier: TTCC-2009-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 12

Brief 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)

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer, panitumumab, TTCC-2009-03

Outcome Measures

Primary Outcomes (1)

• objective response rate

  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).

  2 years

Secondary Outcomes (1)

• Time to response, duration of response, progression free-survival, overall survival.

  2 years

Study Arms (1)

Panitumumab + Paclitaxel

EXPERIMENTAL

Treatment consisted of intravenous panitumumab 6 mg/kg q2w, administered in one hour the first day and in 30 minutes thereafter (if no infusional reaction was observed) plus intravenous paclitaxel 80 mg/m2 weekly administered one hour after panitumumab in one hour infusion, until progression or unacceptable toxicity. Panitumumab does not require prophylactic premedication from the first infusion. Paclitaxel was administered with: dexamethasone 10 mg, diphenhydramine 30 mg and antiH2 (cimetidine 300 mg or ranitidine 50 mg). Dose modifications of paclitaxel included 4.8 mg/kg (80% of the initial dose) and 3.6 mg/kg (60%) when recovered from a grade 3-4 skin toxicity to grade ≤2. Continuing paclitaxel on the day of the planned infusion required no grade ≥2 mucositis and hematologic recovery with an absolute neutrophil count ≥1,500/ml and a platelet count ≥75,000.

Drug: Panitumumab + paclitaxel

Interventions

Panitumumab + paclitaxel DRUG

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.

Also known as: Vectibix®

Panitumumab + Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Grupo Español de Tratamiento de Tumores de Cabeza y Cuello: lead
• Amgen: collaborator
• Trial Form Support S.L.: collaborator

Study Sites (12)

Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital General de Yagüe

Burgos, Spain

Location

H. Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario Fundación Alcorcón

Madrid, 28922, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital General Universitario

Valencia, Spain

Location

Hospital Universitario la Fe de Valencia

Valencia, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Related Publications (1)

• Del Barco Morillo E, Mesia R, Adansa Klain JC, Vazquez Fernandez S, Martinez-Galan J, Pastor Borgonon M, Gonzalez-Rivas C, Caballero Daroqui J, Berrocal A, Martinez-Trufero J, Vera R, Cruz-Hernandez JJ; Spanish Head And Neck Cancer Cooperative Group (TTCC). Phase II study of panitumumab and paclitaxel as first-line treatment in recurrent or metastatic head and neck cancer. TTCC-2009-03/VECTITAX study. Oral Oncol. 2016 Nov;62:54-59. doi: 10.1016/j.oraloncology.2016.09.009. Epub 2016 Oct 8.

  PMID: 27865372 DERIVED

Related Links

• This site would like to expose the activities of the group and at the same time serve as an information and communication tool of this pathology for professionals and patients.

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Panitumumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Juan Jesús Cruz Hernández, Professor

  University of Salamanca

  STUDY DIRECTOR

• Javier Martínez Trufero, 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

  PRINCIPAL INVESTIGATOR

• Elvira del Barco Morillo, MD

  University of Salamanca

  STUDY DIRECTOR

• 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 García, MD

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 21, 2010
• Study Start: March 9, 2011
• Primary Completion: October 1, 2011
• Study Completion: September 29, 2014
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

ES (12)