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A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)


PRIMARY OBJECTIVE:

I. To establish the progression free survival rate at 2 years, using RECIST criteria, to
induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by
chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)

SECONDARY OBJECTIVE:

I. To evaluate complete response rates, safety and feasibility of TPF followed by
chemoradiation in patients with NPC

OUTLINE: This is a single site study.

INDUCTION THERAPY: Patients receive docetaxel IV over 60 minutes on day 1; cisplatin IV over
1-3 hours (or carboplatin IV over 30 minutes) on day 1; and fluorouracil IV continuously
over 24 hours on days 1-5. Treatment repeats every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.

CONCURRENT CHEMORADIOTHERAPY: Beginning within 3-6 weeks after initiating the last course of
induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated
radiotherapy once daily for 6.5-7 weeks. Patients also receive cisplatin IV over 1 hour (or
carboplatin IV over 30 minutes) once weekly in weeks 1-6 in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years.


Inclusion Criteria:



- Histologically or cytologically confirmed nasopharyngeal carcinoma meeting the
following criteria:

- WHO type I, II, or III

- Stage II -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

- No known brain metastases

- ECOG performance status 0-1

- Life expectancy > 3 months

- ANC >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Total bilirubin <= 1.5 times ULN

- AST and 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

- Not pregnant or nursing

- Fertile patients must use effective contraception prior to and during 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.

- No 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

- No clinically significant cardiovascular disease

- No cerebrovascular accident within the past 6 months

- No myocardial infarction or unstable angina within the past 6 months

- No NYHA class II-IV congestive heart failure

- No serious and inadequately controlled cardiac arrhythmia

- No significant vascular disease (e.g., aortic aneurysm, history of aortic
dissection)

- No clinically significant peripheral vascular disease

- No 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

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No prior chemotherapy or radiotherapy for nasopharyngeal carcinoma

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate, using RECIST criteria

Outcome Description:

Estimated according to the methods of Kaplan and Meier.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Alexander Colevas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01162

NCT ID:

NCT00896181

Start Date:

January 2009

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Nasopharyngeal Neoplasms

Name

Location

Stanford University Stanford, California  94305