Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301028

Purpose

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy, with or without cisplatin, may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin and paclitaxel followed by radiation therapy, with or without cisplatin, works in treating patients with metastatic head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: carboplatin Drug: cetuximab Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Carboplatin Cisplatin Paclitaxel Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Outcomes comparison (response rate or quality of life measures) [ Designated as safety issue: No ]
Time to progression [ Designated as safety issue: No ]
Patterns of failure [ Designated as safety issue: No ]
Survival rate [ Designated as safety issue: No ]

Study Start Date:

April 2006

Detailed Description:

OBJECTIVES:

Primary

Determine the increase in clinical/radiographic complete response rate in patients with previously untreated metastatic squamous cell carcinoma of the head and neck treated with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
Determine the toxic effects of this regimen in these patients.

Secondary

Determine the pattern of tumor recurrence in patients treated with this regimen.
Determine the quality of life of patients treated with this regimen.
Determine the duration of response, time to progression, and survival of patients treated with this regimen.
Correlate effects of this regimen with biomarkers of response and predictors of long-term outcome in these patients.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical resection before or instead of radiotherapy or chemoradiotherapy.

Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of radiotherapy or surgery.

After study completion, patients are followed every 3 months for 2 years, every 4 months for 1 year, and every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
- Disease confirmed by primary lesion and/or lymph nodes
Stage IV disease (T0-4; N2b, 2c, 3; M0)
- Stage N1 disease allowed for nasopharynx patients
- Tx primary disease allowed if there is N2b,3 adenopathy
- No clinical or radiographic evidence of distant metastases (below the clavicle)
Measurable disease

PATIENT CHARACTERISTICS:

Age

Over 16

Performance status

Karnofsky 80-100% OR
ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count > 1,500/mm^3
Platelet count > 100,000/mm^3

Hepatic

Bilirubin normal
Meets one of the following criteria:
- ALT and AST ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) normal
- AP ≤ 4 times ULN AND ALT and AST normal
- ALT and AST ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
PT/PTT normal

Renal

Calcium normal (without intervention)
Creatinine clearance > 40 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 weeks after completion of the study treatment
No other malignancy in the past 3 years except nonmelanoma skin cancer
No serious acute or chronic co-morbid condition
No acute infection
No other concurrent invasive cancer
No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior cetuximab
No prior murine or chimeric monoclonal antibody

Chemotherapy

At least 3 years since prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the head or neck

Surgery

No prior surgical resection that would render the patient clinically and radiologically disease-free

Other

No prior drug that targets the epidermal growth factor receptor pathway

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301028

Locations

United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Merrill S. Kies, MD	M.D. Anderson Cancer Center
Investigator:	Vassiliki A. Papadimitrakopoulou, MD	M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000441273, MDA-2003-0919, BMS-CA225054
Study First Received:	March 8, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00301028
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the lip and oral cavity

Study placed in the following topic categories:

Squamous cell carcinoma
Cetuximab
Carboplatin
Dental Caries
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma
Cisplatin

Paclitaxel
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009