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NCT03887442: EXTAX

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

Terminated Phase 2 Results posted Last updated 7 January 2021
What this trial tests

Phase 2 trial testing Paclitaxel in Head and Neck Cancer in 17 participants. Terminated before completion.

Timeline
16 February 2011
Primary endpoint
2 October 2012
2 October 2012

Quick facts

Lead sponsorGrupo Español de Tratamiento de Tumores de Cabeza y Cuello
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment17
Start date16 February 2011
Primary completion2 October 2012
Estimated completion2 October 2012

Drugs / interventions tested

Conditions studied

Sponsor

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello — full company profile →

Who can join

Adults 18 to 75, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Adverse Events Secondary · 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.

GroupValue95% CI
Paclitaxel9
Cetuximab + Paclitaxel8

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Paclitaxel
Serious: 4/9 (44%)
Deaths: 6/9
Cetuximab + Paclitaxel
Serious: 4/8 (50%)
Deaths: 4/8

Serious adverse events (10 terms)

ReactionSystemPaclitaxelCetuximab + Paclitaxel
VomitingGastrointestinal disorders
BronchospasmRespiratory, thoracic and mediastinal disorders
Fracture of humerusInjury, poisoning and procedural complications
Lung infectionInfections and infestations
Pneumococcal pneumoniaInfections and infestations
Abdominal painGastrointestinal disorders
Mouth bleedingGastrointestinal disorders
PneumoniaInfections and infestations
InfectionInfections and infestations
DyspneaRespiratory, thoracic and mediastinal disorders
Other adverse events (89 terms — click to expand)

ReactionSystemPaclitaxelCetuximab + Paclitaxel
Mucosal inflammationGeneral disorders
AstheniaGeneral disorders
AlopeciaSkin and subcutaneous tissue disorders
RashSkin and subcutaneous tissue disorders
DyspneaRespiratory, thoracic and mediastinal disorders
ParesthesiaNervous system disorders
Palmoplantar Erythrodysesthesia SyndromeSkin and subcutaneous tissue disorders
ConstipationGastrointestinal disorders
HypomagnesemiaMetabolism and nutrition disorders
Peripheral neuropathyNervous system disorders
DysphagiaGastrointestinal disorders
DermatitisSkin and subcutaneous tissue disorders
PainGeneral disorders
NauseaGastrointestinal disorders
HemoptysisRespiratory, thoracic and mediastinal disorders
Photosensitivity reactionSkin and subcutaneous tissue disorders
DiarrheaGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
StomatitisGastrointestinal disorders
DysgeusiaNervous system disorders
Dry mouthGastrointestinal disorders
Sensory peripheral neuropathyNervous system disorders
FatigueGeneral disorders
Loss of appetiteMetabolism and nutrition disorders
Productive coughRespiratory, thoracic and mediastinal disorders
PyrexiaGeneral disorders
Skin toxicitySkin and subcutaneous tissue disorders
EdemaGeneral disorders
ErythemaSkin and subcutaneous tissue disorders
Post-surgical wound infectionInfections and infestations
AgeusiaNervous system disorders
DyspepsiaGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
Pain in an extremityMusculoskeletal and connective tissue disorders
Naso-pharyngitisInfections and infestations
BronchitisInfections and infestations
HypoesthesiaNervous system disorders
DysesthesiaNervous system disorders
Oral CandidiasisInfections and infestations
Tracheal painRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Vomiting, Bronchospasm, Fracture of humerus, Lung infection, Pneumococcal pneumonia, Abdominal pain, Mouth bleeding, Pneumonia.

Data from ClinicalTrials.gov NCT03887442 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Paclitaxel

Trials testing the same drug.

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

Other Grupo Español de Tratamiento de Tumores de Cabeza y Cuello trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03887442.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing