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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00896181
First received: May 7, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This phase II 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.


Condition Intervention Phase
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
Drug: docetaxel
Drug: cisplatin
Drug: carboplatin
Drug: fluorouracil
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression free survival rate, using RECIST criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Estimated according to the methods of Kaplan and Meier.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Estimated according to the methods of Kaplan and Meier.

  • Rates of adverse events resulting in treatment discontinuation [ Time Frame: Up to 1 month after completion of study treatment ] [ Designated as safety issue: Yes ]
    The rates of AEs resulting in protocol treatment discontinuation will be estimated using a binomial distribution along with their associated 95% confidence intervals. Only adverse events assessed as definitely, probably, or possibly related to protocol treatment will be considered.


Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

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.

Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Radiation: 3-dimensional conformal radiation therapy
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Other Names:
  • 3D conformal radiation therapy
  • 3D-CRT
Radiation: intensity-modulated radiation therapy
Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Other Name: IMRT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00896181

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Ruth Lira    650-723-1367    rlira@stanford.edu   
Principal Investigator: Alexander D. Colevas         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alexander Colevas Stanford University Hospitals and Clinics
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00896181     History of Changes
Obsolete Identifiers: NCT00841997
Other Study ID Numbers: NCI-2009-01162, NCI-2009-01162, CDR0000671087, 8209, P30CA124435, Stanford University
Study First Received: May 7, 2009
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Carboplatin
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 29, 2014