Phase 2 N=26 Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT00896181 ↗

Enrolled (actual)

Serious AEs

19.2%

Results posted

Apr 2021

Primary outcome: Primary: Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy — 18; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: docetaxel (Drug); cisplatin (Drug); carboplatin (Drug); fluorouracil (Drug); 3-dimensional conformal radiation therapy (Radiation); intensity-modulated radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy	18; 4	—
PRIMARY Median Progression-free Survival (PFS)	76; 33	—
SECONDARY Overall Survival (OS)	79; 76	—
SECONDARY Number of Participants With Adverse Events Resulting in Treatment Discontinuation	1	—
SECONDARY Number of Participants With Treatment Response	17; 3; 0; 0; 3; 1	—

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 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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00896181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.