Head and Neck CancerPhase 2EXTAXNCT03887442

Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy

A Phase 2 study testing Paclitaxel and Cetuximab + Paclitaxel in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) after progression to first line EXTREME-type treatment in patients undergoing maintenance treatment with cetuximab. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Head and Neck Cancer
What is being tested?: Paclitaxel and Cetuximab + Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: No sites listed yet
Study dates: 16 Feb 2011to 2 Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed the informed consent
Age ≥ 18 and < 75 y
ECOG (Eastern Cooperative Oncology Group)performance status: 0-1
Life expectancy of at least 12 weeks
Histological or cytological confirmation of head \& neck squamous cell carcinoma with localization in larynx, oropharynx, oral cavity or hypopharynx.
Having received at least 2 cycles of EXTREME-type chemotherapy (cisplatin or carboplatin + fluoropyrimidines + cetuximab) and being in maintenance phase with cetuximab because of having reached CR (Complete response), PR (Partial response) or SD (Stable disease) to said treatment

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At least one measureable lesion by CT scan or MRI
Adequate bone marrow, liver and kidney function, according to:
Hb (Hemoglobin) ≥ 9.0 g/dl
Platelets 100,000/mm3
ANC (Absolute Neutrophil Count) ≥ 1,500/mm3
Total bilirubin ≤ 2 times the UNL
SGPT/ALT and SGOT/AST ≤ 3 x UNL (Upper normal limit)
Alkaline phosphatase ≤ 2.5 x UNL
Serum creatinine ≤ 1.5 times the ULN or creatinine clearance > 50 ml/min
Adequate nutritional status: weight loss < 20% in relationship to usual weight or albumin ≥ 35 g/l, in the last 12 w
Seric calcium adjusted to albumine lower or equal to 1,25 UNL.
Toxicity, due to previous treatment received, resolved to grade 1, before enrolment in the study
Women of childbearing potential should have a (-)ve pregnancy test in serum or urine,7 d before randomization. Postmenopausal women should have remained amenorrheic for at least 12 m. Furthermore, all men as well as women who participate in this study should use effective contraceptive methods beginning with the signing of the informed consent form and up to at least 6 m after the completion of the study or of the last dose, whichever occurs first

Who cannot join

Treatment for recurrent and/or metastatic disease other than the EXTREME- type first line (cisplatin or carboplatin + fluoropyrimidines + cetuximab)
Non-measurable lesion as only evidence of disease
Nasopharyngeal carcinoma
Clinical or radiographic evidence of brain metastases
Having history of or presenting clinically significant cardiovascular disease, such as, but not limited to, congestive heart failure, ≥ grade II of the NYHA, severe cardiac arrhythmias that require medication, or ≥ grade II peripheral vascular disease. Furthermore, those patients who have suffered myocardial infarction or unstable angina in the year prior to the onset of the study treatment or a recent onset angina in the last 3 m will also be excluded
History of or current presence of grade >1 peripheral neuropathy

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History of active neurological disease
History of uncontrolled convulsive episode
Current ≥ 2 grade infection
Known infection by HIV or chronic infection by HBV or HBC or presence of uncontrolled and severe intercurrent infections or other severe and uncontrolled concomitant diseases
History of uncontrolled diabetes, uncontrolled HBP or hepatic condition.
History of pulmonary fibrosis, acute pulmonary damage or interstitial pneumonia
Any antineoplastic treatment within the 4 w prior to the randomization period
History of another neoplastic disease during the last 5 y, with the exception of cured "in situ" basal cell ca.skin carcinoma, "in situ" ca.bladder, "in situ" ca.cervix and "in situ" ca.prostate
Known allergy or suspicion of allergy or hypersensitivity to any component of cetuximab or paclitaxel
Previous treatment with monoclonal antibodies or other signal transduction inhibitors or EGFR-targeted treatment (Except for previous treatment with cetuximab)
Known drug abuse (exception Alcoholism)
Any important and uncontrolled medical, psychological, psychiatric, geographic or social problem that may interfere in the participation of the subject in the study and that does not allow for adequate follow-up and compliance with the protocol and evaluation of the study results
Women who are pregnant or in breast-feeding period
Use of any investigational new drug within the 4 w prior to randomization

About this study

Official title: Phase II, Randomized Clinical Trial to Assess the Efficacy of Paclitaxel vs Paclitaxel + Cetuximab in Subjects With Recurrent and/or Metastatic Squamous Head & Neck Carcinoma After Failure of a 1º Line Chemotherapy EXTREME Type Treatment

Conditions: Head and Neck Cancer
Being tested: Paclitaxel, Cetuximab + Paclitaxel
Keywords: Head and Neck Cancer, Cetuximab, Erbitux, Paclitaxel, Extreme, Metastatic, Recurrent
Medical subject headings: Head and Neck Neoplasms, Neoplasm Metastasis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PaclitaxelDrug
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
Cetuximab + PaclitaxelDrug
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.

Study groups in NCT03887442
Study group	Role	What they receive
Paclitaxel	Active comparator	Paclitaxel 80 mg/m2 may be infused, intravenously, every week. Receives: Drug: Paclitaxel
Cetuximab + Paclitaxel	Experimental	Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel. Receives: Drug: Cetuximab + Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
The primary endpoint was to select the most effective treatment arm based on the progression-free survival (PFS) reached in each treatment arm. This was defined as the time elapsed from inclusion in the study until the date when disease progression or death (for any cause) was documented.
Measured: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.

Secondary outcomes (4)

Overall Survival
Calculate overall survival (OS) in both arms
Measured: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The secondary endopoint was not analyzed.
Percentage of Objective Response
Calculate the percentage of objective responses (OR), following the new RECIST criteria, obtained in both arms
Measured: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. Neither the primary nor the secondary endopoints were analyzed.
Participants With Adverse Events
To perform a descriptive analysis of the adverse events observed in the patients included in the study. Further analysis could not be performed due to early closure of this study due to lack of accrual. Adverse events were registered from study entry until 60 days after receiving the last dose of study drug.
Measured: The duration of the study (Nineteen months) and until the last patient included completed one year of follow up / died or was lost to FU. Adverse events were registered from study entry until 60 days after receiving the last dose of study drug.
Treatment Compliance
Evaluate treatment compliance rate in both treatment arms, in order to analyze it, the dose intensity would be calculated as the quantity of each of the administered study drugs per unit of time (mg/m2/week) regardless of the treatment arm. To analyze the relative dose intensity, the dose of each administered drug will be divided per a unit of time and the planned quantity of each drug according to the doses described in the protocol.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 20112 Oct 2012

First posted25 Mar 2019
Study start16 Feb 2011
Primary completion2 Oct 2012
Study completion2 Oct 2012

Why it stopped: low recruitment rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03887442
Sponsor's protocol ID: TTCC-2009-04
Acronym: EXTAX
Status last verified: Dec 2020
First submitted: 11 Feb 2011
Last updated: 7 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Head and Neck Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized Clinical Trial to Assess the Efficacy of Paclitaxel vs Paclitaxel + Cetuximab in Subjects With Recurrent and/or Metastatic Squamous Head & Neck Carcinoma After Failure of a 1º Line Chemotherapy EXTREME Type Treatment
ClinicalTrials.gov ID: NCT03887442
Acronym / sponsor ID: EXTAX / TTCC-2009-04
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer, Cetuximab, Erbitux, Paclitaxel, Extreme, Metastatic, Recurrent
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: low recruitment rate
Enrolment: 17 participants (actual)
Lead sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y CuelloUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, Pivotal S.L.
Study start: 16 Feb 2011 (actual)
Primary completion: 2 Oct 2012 (actual)
Study completion: 2 Oct 2012 (actual)
First posted: 25 Mar 2019 (actual)
Results: Posted 9 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paclitaxel	Active comparator	Drug: PaclitaxelPaclitaxel 80 mg/m2 may be infused, intravenously, every week.
Cetuximab + Paclitaxel	Experimental	Drug: Cetuximab + PaclitaxelCetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Signed the informed consent
Age ≥ 18 and < 75 y
ECOG (Eastern Cooperative Oncology Group)performance status: 0-1
Life expectancy of at least 12 weeks
Histological or cytological confirmation of head \& neck squamous cell carcinoma with localization in larynx, oropharynx, oral cavity or hypopharynx.

Key exclusion criteria (20 listed)

Treatment for recurrent and/or metastatic disease other than the EXTREME- type first line (cisplatin or carboplatin + fluoropyrimidines + cetuximab)
Non-measurable lesion as only evidence of disease
Nasopharyngeal carcinoma
Clinical or radiographic evidence of brain metastases
Having history of or presenting clinically significant cardiovascular disease, such as, but not limited to, congestive heart failure, ≥ grade II of the NYHA, severe cardiac arrhythmias that require medication, or ≥ grade II peripheral vascular disease. Furthermore, those patients who have suffered myocardial infarction or unstable angina in the year prior to the onset of the study treatment or a recent onset angina in the last 3 m will also be excluded

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
PaclitaxelPaclitaxel 80 mg/m2 may be infused, intravenously, every week.	Drug	Paclitaxel
Cetuximab + PaclitaxelCetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.	Drug	Cetuximab + Paclitaxel

Primary outcome

Progression Free Survival (PFS)
Time frame: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.
The primary endpoint was to select the most effective treatment arm based on the progression-free survival (PFS) reached in each treatment arm. This was defined as the time elapsed from inclusion in the study until the date when disease progression or death (for any cause) was documented.

4 secondary outcomes

Overall Survival
Time frame: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The secondary endopoint was not analyzed.
Percentage of Objective Response
Time frame: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. Neither the primary nor the secondary endopoints were analyzed.
Participants With Adverse Events
Time frame: The duration of the study (Nineteen months) and until the last patient included completed one year of follow up / died or was lost to FU. Adverse events were registered from study entry until 60 days after receiving the last dose of study drug.
Treatment Compliance
Time frame: 3 years

Results and safety

Results posted to the registry on 9 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paclitaxel	9	8
Cetuximab + Paclitaxel	8	8

Primary outcome: Progression Free Survival (PFS)

Time frame: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.

Population analysed: Only 17 patients out of a planned protocol number of 80 were recruited to the study, owing to premature closure of the study. Two of those patients did not meet some of the inclusion and/or exclusion criteria. Database lock: 3 June 2013. There were insufficient numbers of patients to be able to analyse the efficacy endpoints. The possible discrepancies that were pending resolution have been closed as "Premature closure of the study. Deviation DN13/024". .

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected across the duration of study treatment. This was during the 19 months the study was open until 60 days after the last patient being treated received the last dose of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paclitaxel	4 of 9 (44.4%)	9 of 9 (100%)	6 of 9
Cetuximab + Paclitaxel	4 of 8 (50%)	8 of 8 (100%)	4 of 8

Limitations and caveats (from the sponsor): After 19 mos. the study was prematurely closed due to lack of accrual, only 17 pts were included. It was not possible to analyze the 1ry nor the 2ry endpoints of the study. A safety analysis was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Head and Neck Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

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.

Ricard Mesía, MD principal investigator

Institut Català d´Oncologia-Duran i Reynals

Juan J. Grau, MD principal investigator

Hospital Clinic of Barcelona

Elvira del Barco, MD principal investigator

University of Salamanca

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Cetuximab + Paclitaxel in people with Head and Neck Cancer, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello.

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 19 inclusion and 20 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: stopped early, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) (time frame: Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.). 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 NCT03887442.

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 7 Jan 2021.