Status:
COMPLETED
Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
Lead Sponsor:
Stanford University
Conditions:
Stage II Lymphoepithelioma of the Nasopharynx
Stage II Squamous Cell Carcinoma of the Nasopharynx
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 pat...
Detailed Description
PRIMARY OBJECTIVE: • To establish the progression free survival rate at 2 years, using RECIST criteria, to induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by chemoradio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00896181
Start Date
December 10 2008
End Date
December 1 2020
Last Update
April 6 2021
Active Locations (1)
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1
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305