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Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
Not Recruiting
Trial ID: NCT00896181
Purpose
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.
Official Title
A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
Stanford Investigator(s)
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Eligibility
INCLUSION CRITERIA
- 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
EXCLUSION CRITERIA
- 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
Intervention(s):
drug: carboplatin
drug: fluorouracil
radiation: 3-dimensional conformal radiation therapy
radiation: intensity-modulated radiation therapy
drug: docetaxel
drug: cisplatin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Risa Jiron
650-736-1598