- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887442
Paclitaxel vs Paclitaxel + Cetuximab in Recurrent - Metastatic Head & Neck Carcinoma After Failure of a 1º Chemotherapy (EXTAX)
December 11, 2020 updated by: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Paclitaxel
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
|
Experimental: Cetuximab + Paclitaxel
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week.
Cetuximab will be administered prior to paclitaxel.
|
Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week.
Cetuximab will be administered prior to paclitaxel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The primary endopoint was not analyzed.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Calculate overall survival (OS) in both arms
|
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.
|
Calculate the percentage of objective responses (OR), following the new RECIST criteria, obtained in both arms
|
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.
|
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.
|
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
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ricard Mesía, MD, Institut Català d´Oncologia-Duran i Reynals
- Principal Investigator: Juan J. Grau, MD, Hospital Clinic of Barcelona
- Principal Investigator: Elvira del Barco, MD, University of Salamanca
- Principal Investigator: Ruth Vera, MD, Complejo Hospitalario de Navarra
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2011
Primary Completion (Actual)
October 2, 2012
Study Completion (Actual)
October 2, 2012
Study Registration Dates
First Submitted
February 11, 2011
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 25, 2019
Study Record Updates
Last Update Posted (Actual)
January 7, 2021
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTCC-2009-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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