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

NCT00896181 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: IRB-15411NCI-2009-01162CDR00006710878209ENT0025
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Progression-free Survival (PFS) at 2 Years After Chemo-radiotherapy

  Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the number of patients remaining alive at 2 years following chemo-radiotherapy without disease progression, a number without dispersion.

  up to 29 months (ie, 24 months post-chemoradiation)

• Median Progression-free Survival (PFS)

  Progression-free survival (PFS) means to remain alive without disease progression. Progression is defined as either the appearance of one or more new cancer lesions, or a ≥ 20% increase in the sum of the longest diameters (LD) of target cancer lesions, compared the same measurement obtained at the start of treatment. This outcome reported as the median duration of PFS in months since chemo-radiotherapy, with full range.

  up to 127 months (includes treatment period of up to 5 months)

Secondary Outcomes (3)

• Overall Survival (OS)

  up to 127 months (includes treatment period of up to 5 months)

• Number of Participants With Adverse Events Resulting in Treatment Discontinuation

  8 months

• Number of Participants With Treatment Response

  up to 29 months (ie, 24 months post-chemoradiation)

Study Arms (1)

Chemoradiation for Nasopharyngeal Carcinoma

EXPERIMENTAL

INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity. CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity.

Drug: docetaxel; Drug: cisplatin; Drug: carboplatin; Drug: fluorouracil; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy

Interventions

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Chemoradiation for Nasopharyngeal Carcinoma

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Chemoradiation for Nasopharyngeal Carcinoma

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Chemoradiation for Nasopharyngeal Carcinoma

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Chemoradiation for Nasopharyngeal Carcinoma

3-dimensional conformal radiation therapy RADIATION

Undergo 3-dimensional conformal or intensity-modulated radiotherapy

Also known as: 3D conformal radiation therapy, 3D-CRT

Chemoradiation for Nasopharyngeal Carcinoma

intensity-modulated radiation therapy RADIATION

Undergo 3-dimensional conformal or intensity-modulated radiotherapy

Also known as: IMRT

Chemoradiation for Nasopharyngeal Carcinoma

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Related Publications (1)

• Jun M, Pinto H, Le QT, Quon A, Hara W, Coty J, McMillan A, Lu R, Winters E, Lira R, Colevas AD. In search for optimal induction chemotherapy for advanced nasopharyngeal cancer: Standard dosing of Docetaxel, Platinum, and 5-Fluorouracil (TPF) followed by chemoradiation. PLoS One. 2023 Feb 2;18(2):e0276651. doi: 10.1371/journal.pone.0276651. eCollection 2023.

  PMID: 36730145 DERIVED

MeSH Terms

Interventions

Docetaxel; Cisplatin; Carboplatin; Fluorouracil; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. A. Dimitrios Colevas, Professor of Medicine (Oncology)
• Organization: Stanford University

colevas@stanford.edu

650-724-9707

Study Officials

• Alexander Colevas

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Oncology)

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: December 10, 2008
• Primary Completion: January 3, 2020
• Study Completion: December 1, 2020
• Last Updated: April 6, 2021
• Results First Posted: April 6, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)