Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

Completed · Phase 2

Conditions studied: Stage II Lymphoepithelioma of the Nasopharynx, Stage II Squamous Cell Carcinoma of the Nasopharynx, Stage III Lymphoepithelioma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx

In brief

This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00896181

Run by

Stanford University

People needed

26

Starts

2008-12-10

Expected to finish

2020-12-01

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically- or cytologically-confirmed nasopharyngeal carcinoma meeting the following criteria:
• WHO type I, II, or III
• Stage II to IVB disease (minimally T2a, N0, M0 or any T any, N1, M0)
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Prior diagnostic surgery(s) at the primary site or neck allowed provided there is still measurable disease present
• Without known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Life expectancy > 3 months
• Absolute neutrophil count (ANC) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 times ULN
• Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 55 mL/min (NOTE: * Patients with creatinine > grade 1 but < grade 3, hearing loss ≥ grade 2, and peripheral neuropathy ≥ grade 2 are eligible provided they receive carboplatin in place of cisplatin throughout study treatment)
• Hearing loss < grade 2. Hearing loss grade 2 or greater attributable to tumor obstruction, when the bone conduction in the audiogram is consistent with less than grade 2, is permissible for cisplatin. Hearing loss will be evaluated by hearing in the best ear. If hearing loss is grade 2, patients are still eligible but should receive carboplatin throughout the protocol instead of cisplatin.
• Peripheral motor/sensory neuropathy < grade 2. If peripheral neuropathy is grade 2, patients are still eligible but should receive carboplatin throughout the protocol instead of cisplatin.
• Fertile patients must use effective contraception prior to and during study treatment

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness or social situations that preclude compliance with study requirements
• Clinically-significant cardiovascular disease
• Cerebrovascular accident within the past 6 months
• Myocardial infarction or unstable angina within the past 6 months
• New York Heart Association (NYHA) class II to IV congestive heart failure
• Serious and inadequately controlled cardiac arrhythmia
• Significant vascular disease (eg, aortic aneurysm, history of aortic dissection)
• Clinically-significant peripheral vascular disease
• History of allergic reaction attributed to compounds of similar chemical or biologic composition to docetaxel, cisplatin, carboplatin, fluorouracil, bevacizumab, or other agents used in this study
• Known brain metastases
• Concurrent combination antiretroviral therapy for HIV-positive patients
• Prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
• Pregnant or nursing

Where it is running

• Stanford University Hospitals and Clinics — Stanford, California, United States

Full record on ClinicalTrials.gov

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