Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

NCT01437449 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB-22329SU-08222011-8290NCI-2011-03271ENT0033
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.

Conditions

Head and Neck Cancer

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria

  8 weeks

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

• Grade 3, 4, and 5 Related Adverse Events (Toxicities)

  2 years

Study Arms (1)

Cisplatin + Docetaxel + Cetuximab

EXPERIMENTAL

Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.

Drug: Docetaxel; Drug: Cisplatin; Drug: Cetuximab; Drug: Carboplatin

Interventions

Docetaxel DRUG

30 mg/m² by intravenous (IV) administration

Also known as: Taxotere

Cisplatin + Docetaxel + Cetuximab

Cisplatin DRUG

30 mg/m² by intravenous (IV) administration

Also known as: Cisplatinum, Platinol

Cisplatin + Docetaxel + Cetuximab

Cetuximab DRUG

400 mg/m² by intravenous (IV) administration, thereafter 250 IV

Also known as: Erbitux

Cisplatin + Docetaxel + Cetuximab

Carboplatin DRUG

Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration

Also known as: Paraplatin

Cisplatin + Docetaxel + Cetuximab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Squamous cell carcinoma (SCC) of head and neck (SCCHN), including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites. Patients with SCC of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites are eligible.
• If prior chemoradiation, radiation, and/or surgery in the potentially curative setting, \> 3 months has elapsed since the end of the potentially curative treatment ended
• If history of other malignancies treated curatively \> 1 year prior to enrollment, no evidence of relapse at the time of enrollment
• If brain metastasis, central nervous system (CNS) imaging documents no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation)
• ≥ 16 years old
• Eastern cooperative oncology group (ECOG) Performance Status \< 3
• Laboratory value requirements at enrollment:
• Absolute neutrophil count \> 1500/mm³
• Platelet count \> 100,000/mm³
• Hemoglobin \> 8 g/dL
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) unless liver metastases documented. If so, AST and ALT \< 5 x ULN required.
• Total bilirubin \< 1.5 x ULN, EXCEPT if Gilbert's syndrome is present. If so, total bilirubin \< 2.5 x ULN
• Serum Creatinine \< 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection \> 50 mL/min
• Peripheral neuropathy \< grade 2
• Hearing loss in best ear \< grade 2 per Chang criteria if audiogram performed. Formal audiology is not required in patients with no clinical evidence of hearing loss at baseline.

You may not qualify if:

• Prior palliative chemotherapy
• Active infections including HIV (EXCEPTION: HIV-positive patients on HAART with undetectable blood HIV levels, or with history or serological evidence of exposure to Hepatitis B without active infection are eligible)
• Prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab (EXCEPTION: a history of infusion reactions that were well-tolerated, at physician's discretion)
• Pregnant and/or lactating

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

University of California Davis Medical Center

Davis, California, 95616, United States

Location

Stanford University, School of Medicine

Stanford, California, 95305, United States

Location

Related Publications (1)

• Trieu V, Pinto H, Riess JW, Lira R, Luciano R, Coty J, Boothroyd D, Colevas AD. Weekly Docetaxel, Cisplatin, and Cetuximab in Palliative Treatment of Patients with Squamous Cell Carcinoma of the Head and Neck. Oncologist. 2018 Jul;23(7):764-e86. doi: 10.1634/theoncologist.2017-0618. Epub 2018 Mar 14.

  PMID: 29540603 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Cetuximab; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Results Point of Contact

• Title: Dr. A. Dimitrios Colevas, Professor of Medicine (Oncology)
• Organization: Stanford University

colevas@stanford.edu

650-724-9707

Study Officials

• A. Dimitrios Colevas, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Oncology) and Otolaryngology

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 20, 2011
• Study Start: October 1, 2011
• Primary Completion: September 11, 2018
• Study Completion: August 1, 2019
• Last Updated: January 30, 2024
• Results First Posted: December 17, 2019

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)