Docetaxel, Cisplatin, and Cetuximab in Treating Patients with Metastatic or Relapsed Head and Neck Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive16 and overENT0033
NCI-2011-03271, 22329, SU-08222011-8290, NCT01437449

Trial Description

Summary

This phase II trial studies how well docetaxel, cisplatin, and cetuximab work in treating patients with squamous cell carcinoma of the head and neck that has spread to the primary site to other places in the body or has come back after a period of improvement. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as cetuximab, interfere with the ability of tumor cells to grow and spread. Giving docetaxel together with cisplatin and cetuximab may be an effective treatment for head and neck cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To establish the response rate using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to weekly docetaxel, cisplatin, and cetuximab (TPC) in patients with metastatic or relapsed squamous cell carcinoma of the head and neck.

SECONDARY OBJECTIVES:

I. To establish the safety profile, progression free and overall survival of weekly TPC in this patient population.

OUTLINE:

Patients receive docetaxel intravenously (IV) over 30 minutes, cisplatin IV or carboplatin IV over 30 minutes, and cetuximab IV over 60-120 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may receive an additional 2 courses of treatment. Treatment with cetuximab may continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Eligibility Criteria

Inclusion Criteria:

Squamous cell carcinoma of head and neck sites, including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites; patients with a diagnosis of nasopharyngeal carcinoma, or squamous cell carcinoma (SCC) of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites, are eligible

Patients who have received prior chemoradiation, radiation, and/or surgery in the potentially curative setting are eligible as long as 3 months has elapsed since the end of the potentially curative treatment ended

Eastern Cooperative Oncology Group (ECOG) performance status < 3 at enrollment is required

Absolute neutrophil count >= 1500/mm^3

Platelet count >= 100 K/mm^3

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) unless liver metastases documented; in this latter case, AST and ALT < 5 x ULN required

Total bilirubin < 1.5 x ULN unless the patient has Gilbert’s syndrome, in which case total (T) bilirubin < 2.5 x ULN required

Serum creatinine =< 1.5 mg/dL OR an estimated creatinine clearance from 24 hour urine collection >= 50 ml/min

Peripheral neuropathy < grade 2

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

No prior palliative chemotherapy

Patients with active infections including known human immunodeficiency virus (HIV) are not eligible; HIV positive patients on highly active anti-retroviral therapy (HAART) with undetectable blood HIV levels are eligible; patients with a history or serological evidence of exposure to hepatitis B without active infection are eligible for this study

Patients with prior grade 3 allergic or infusion reactions to docetaxel, cisplatin or cetuximab are not eligible; a history of well tolerated infusion reactions is NOT an exclusion

Pregnant women and/or nursing patients will be excluded from the study

Patients with a history of other malignancies treated curatively greater than one year prior to enrollment and without evidence of relapse at the time of enrollment are eligible

Patients with known brain metastasis are eligible only if by central nervous system (CNS) imaging there is no evidence of CNS progression at least 30 days following definitive CNS treatment (resection or radiation)

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Stanford Cancer Institute Palo Alto

  • National Cancer Institute
Alexander Dimitrios Colevas, Principal Investigator

Trial Sites

U.S.A.

California
Palo Alto

Stanford Cancer Institute Palo Alto

Alexander Dimitrios Colevas
Ph: 650-724-9707
Email: colevas@stanford.edu

Alexander Dimitrios Colevas
Principal Investigator

Sacramento

University of California Davis Comprehensive Cancer Center

Jonathan W. Riess
Ph: 916-734-3771
Email: jonathan.riess@ucdmc.ucdavis.edu

Jonathan W. Riess
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01437449

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.