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

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello0 sites17 target enrollmentFebruary 16, 2011

ConditionsHead and Neck Cancer

InterventionsPaclitaxel Cetuximab + Paclitaxel

Overview

Phase: Phase 2
Intervention: Paclitaxel
Conditions: Head and Neck Cancer
Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Enrollment: 17
Primary Endpoint: Progression Free Survival (PFS)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 16, 2011

End Date

October 2, 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Paclitaxel

Paclitaxel 80 mg/m2 may be infused, intravenously, every week.

Intervention: Paclitaxel

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.

Intervention: Cetuximab + Paclitaxel

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Treatment Compliance(3 years)
Percentage of Objective Response(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.)
Overall Survival(Through study completion. The study was prematurely closed at 19 months due to lack of accrual. The secondary endopoint was not analyzed.)
Participants With Adverse Events(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.)