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

NCT03887442 | Terminated Phase 2 Results

• 1 other identifier: TTCC-2009-04
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Cetuximab; Erbitux; Paclitaxel; Extreme; Metastatic; Recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  3 years

Study Arms (2)

Paclitaxel

ACTIVE COMPARATOR

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

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.

Drug: Cetuximab + Paclitaxel

Interventions

Paclitaxel DRUG

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

Paclitaxel

Cetuximab + Paclitaxel DRUG

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

Cetuximab + Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Español de Tratamiento de Tumores de Cabeza y Cuello: lead
• Merck Sharp & Dohme LLC: collaborator
• Pivotal S.L.: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

Paclitaxel; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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.

Results Point of Contact

• Title: Carmen Montalbán, Manager
• Organization: TTCC Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

ttccmanager@yahoo.com

+34676154172

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: March 25, 2019
• Study Start: February 16, 2011
• Primary Completion: October 2, 2012
• Study Completion: October 2, 2012
• Last Updated: January 7, 2021
• Results First Posted: December 9, 2020

Record last verified: 2020-12