Cetuximab, Paclitaxel, and Carboplatin in Treating Patients with Recurrent or Metastatic Head and Neck Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and overLCCC1330
NCI-2015-00334, NCT02124707

Trial Description

Summary

This phase II trial studies how well cetuximab, paclitaxel, and carboplatin work in treating patients with head and neck cancer that began in squamous cells (thin, flat cells that form the surface of the skin, eyes, various internal organs, and the lining of hollow organs and ducts of some glands) and has come back (recurrent) or has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cetuximab, paclitaxel, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Further Study Information

PRIMARY OBJECTIVES:

I. To estimate overall survival (OS) in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab.

SECONDARY OBJECTIVES:

I. To estimate overall response (OR) after study treatment in recurrent or metastatic SCCHN after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks.

II. To estimate progression-free survival (PFS) in recurrent or metastatic SCCHN patients treated with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetixumab.

III. To characterize grade 3 and 4 toxicities associated with this regimen as assessed via clinician assessment.

IV. To describe patient-reported symptoms associated with this regimen in SCCHN.

V. To evaluate the impact of weekly carboplatin, paclitaxel and cetuximab on quality of life as measured by the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) questionnaire.

VI. To estimate OS, PFS, and OR in human papillomavirus positive (HPV+) and human papillomavirus negative (HPV-) patients separately (pre-planned subgroup analysis).

VII. To explore associations between OS, PFS, and OR with genetic information acquired from co-enrollment on LCCC1108 (University of North Carolina [UNC] patients only).

OUTLINE:

Patients receive cetuximab intravenously (IV) over 60-120 minutes, paclitaxel IV over 30 minutes, and carboplatin IV over 30 minutes on day 1 of each week for up to 6 weeks in the absence of disease progression or unacceptable toxicity. At the discretion of the treating physician, patients who achieve at least stable disease (SD) may continue treatment with weekly cetuximab as maintenance until disease progression.

After completion of study treatment, patients are followed up at 8-12 weeks and then every 3-6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed recurrent or metastatic SCCHN

All primary sites are eligible excluding World Health Organization (WHO) type III or Epstein–Barr virus (EBV) nasopharyngeal (WHO type I and WHO type II allowed as long as they are EBV negative)

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Absolute neutrophil count (ANC) >= 1,500/mm^3

Platelets >= 100,000/mm^3

Hemoglobin (HgB) > 9 g/dL (acceptable to reach this by transfusion)

Total bilirubin =< 1.5 mg/dL

Albumin > 2.5 g/dL

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal

Alkaline phosphatase =< 2.5 x upper limit of normal

Glomerular filtration rate (GFR) > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)

Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test within 7 days of day 1 (D1) of treatment

WOCBP and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care

Cancer must be considered incurable by the treating clinician

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

Exclusion Criteria:

History of prior cumulative exposure to >= 300 mg/m^2 cisplatin, area under the curve (AUC) of 18 of carboplatin, or their combined equivalent within one year prior to enrollment

Surgery or definitive radiation within the four weeks prior to D1 of treatment under this protocol (there is no restriction on timing of palliative radiation)

Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry

Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion

Pregnant or lactating female

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

UNC Lineberger Comprehensive Cancer Center

  • National Cancer Institute
Jared Weiss, Principal Investigator

Trial Sites

U.S.A.

North Carolina
Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Jared Weiss
Ph: 919-966-3856
Email: Jared_Weiss@med.unc.edu

Jared Weiss
Principal Investigator

Virginia
Midlothian

Bon Secours Saint Francis Medical Center

William Johnson Irvin
Ph: 804-893-8717
Email: william_irvin@bshsi.org

William Johnson Irvin
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02124707

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.