Head and Neck CancerPhase 2VECTITAXNCT01264328
Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer
A Phase 2 study testing Panitumumab + paclitaxel in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 12 sites in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Panitumumab + paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 12 sitesSpain
- Study dates
- 9 Mar 2011to 29 Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital General de Yagüe
Burgos
H. Virgen de las Nieves
Granada
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona
Hospital Universitario Fundación Alcorcón
Madrid, 28922
Hospital Universitario 12 de Octubre
Madrid
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital General Universitario
Valencia
Hospital Universitario la Fe de Valencia
Valencia
Hospital Miguel Servet
Zaragoza
About this study
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"
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)
Read the detailed description
Panitumumab, a fully human IgG2 anti-EGFR monoclonal antibody, has shown activity in preclinical models of SCCHN, and promising activity in refractory SCCHN patients in a phase I clinical trial. Recently, the investigators also reported encouraging outcomes of anti-EGFR-paclitaxel combination in a phase II study. On the basis of this background, a phase II clinical trial (VECTITAX study) was designed with the objective of evaluating the activity and safety profile of panitumumab in combination with paclitaxel in patients with recurrent or metastatic SCCHN.
The VECTITAX study was a single arm, open label, multicenter, phase II clinical trial. To be included patients had to have histologically or cytologically confirmed SCCHN. The current situation had to be recurrent or metastatic, deemed to be untreatable by surgery or radiotherapy. No previous systemic antineoplastic therapy for the recurrent/metastatic disease may have been administered. However, previous chemotherapy was allowed as a part of a multimodality radical treatment if completed >24 weeks before study entry.
Primary endpoint was confirmed objective response rate (ORR) according to RECIST 1.1 criteria in the intention-to-treat population (ITT). Tumor assessments were planned to be performed every two months. Response confirmation was to be assessed not before 4 weeks after a partial or complete response, or before 6 weeks after a stable disease. Secondary endpoints were disease control rate, time to response, duration of response, progression-free survival (PFS), OS, safety profile and QoL through EQ-5D-3L with visual analogic scale (VAS). Quality of life scores were registered at baseline and every eight weeks thereafter.
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Panitumumab + paclitaxel
- Keywords
- Head and neck cancer, panitumumab, TTCC-2009-03
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab + paclitaxelDrug
Also called Vectibix®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Panitumumab + paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (1)
Time to response, duration of response, progression free-survival, overall survival.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study start9 Mar 2011
- Primary completionOct 2011
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Trial Form Support S.L.
- Responsible party
- Sponsor
- Investigators
- Juan Jesús Cruz Hernández, Professor, Study director, University of SalamancaJavier Martínez Trufero, MD, Principal investigator, Hospital Miguel Servet de ZaragozaJuan José Grau, MD, Principal investigator, Hospital Clínic i Provincial de BarcelonaJoaquina Martínez, MD, Principal investigator, University Hospital Virgen de las NievesAntonio López Pousa, MD, Principal investigator, Hospital de la Santa Creu i Sant Pau de BarcelonaAlfonso Berrocal, MD, Principal investigator, Hospital General Universitario de ValenciaRicardo Hitt, MD, Principal investigator, Hospital 12 de Octubre de MadridRicardo Mesia, MD, Principal investigator, Institut Català d'Oncología. Hospital Duran i Reynals de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264328
- Sponsor's protocol ID
- TTCC-2009-03
- Acronym
- VECTITAX
- Status last verified
- Apr 2019
- First submitted
- 2 Dec 2010
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27865372
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01264328
- Acronym / sponsor ID
- VECTITAX / TTCC-2009-03
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, panitumumab, TTCC-2009-03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- Amgen, Trial Form Support S.L.
- Study start
- 9 Mar 2011 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- 29 Sep 2014 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Panitumumab, a fully human IgG2 anti-EGFR monoclonal antibody, has shown activity in preclinical models of SCCHN, and promising activity in refractory SCCHN patients in a phase I clinical trial. Recently, the investigators also reported encouraging outcomes of anti-EGFR-paclitaxel combination in a phase II study. On the basis of this background, a phase II clinical trial (VECTITAX study) was designed with the objective of evaluating the activity and safety profile of panitumumab in combination with paclitaxel in patients with recurrent or metastatic SCCHN.
The VECTITAX study was a single arm, open label, multicenter, phase II clinical trial. To be included patients had to have histologically or cytologically confirmed SCCHN. The current situation had to be recurrent or metastatic, deemed to be untreatable by surgery or radiotherapy. No previous systemic antineoplastic therapy for the recurrent/metastatic disease may have been administered. However, previous chemotherapy was allowed as a part of a multimodality radical treatment if completed >24 weeks before study entry.
Primary endpoint was confirmed objective response rate (ORR) according to RECIST 1.1 criteria in the intention-to-treat population (ITT). Tumor assessments were planned to be performed every two months. Response confirmation was to be assessed not before 4 weeks after a partial or complete response, or before 6 weeks after a stable disease. Secondary endpoints were disease control rate, time to response, duration of response, progression-free survival (PFS), OS, safety profile and QoL through EQ-5D-3L with visual analogic scale (VAS). Quality of life scores were registered at baseline and every eight weeks thereafter.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab + Paclitaxel | Experimental | Drug: Panitumumab + paclitaxelTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- Clinically significant cardiovascular disease ≤ 1 year prior to starting the study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panitumumab + paclitaxelAlso: Vectibix®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. | Drug | Panitumumab + Paclitaxel |
Primary outcome
objective response rate
Time frame: 2 years
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).
1 secondary outcome
Time to response, duration of response, progression free-survival, overall survival.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 27865372Del 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Jesús Cruz Hernández, Professor study director
University of Salamanca
Javier Martínez Trufero, MD principal investigator
Hospital Miguel Servet de Zaragoza
Juan José Grau, MD principal investigator
Hospital Clínic i Provincial de Barcelona
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab + paclitaxel in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01264328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.