Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

NCT00367718 | Withdrawn Phase 2

• 1 other identifier: CTRG-NP04/23/06
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

Brief Summary

This study seeks to test the Efficacy in terms of rates of disease response in metastatic nasopharyngeal carcinoma of the standard dose of velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule. The study uses a Simons 2 stage design and will enroll between 15-25 patients. Secondary endpoints studied include Pharmacokinetics, toxicities, EBV viral load and molecular characterization of EBV in plasma.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Efficacy based on response of measurable disease

  duration of study (4 -6 months)

Secondary Outcomes (3)

• EBV viral load

  duration of study (4 -6 months)

• toxicities

  duration of study (4 -6 months)

• molecular characterization of EBV in Plasma

  duration of study (4 -6 months)

Interventions

Velcade DRUG

velcade 1.3 mg/m2 given at the day 1,4,8,and 11 every 21 days schedule.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven nasopharyngeal carcinoma - WHO type 3 (recurrence or metastases)
• metastatic disease or locally recurrent disease not amendable curative therapy
• Patients must have measurable disease
• least one (not more than a total of three prior lines of chemotherapy for metastatic or recurrent disease). This must include at least 1 prior line of platinum-containing chemotherapy.
• An ECOG performance status of 0-2
• Absolute neutrophil count (ANC) ≥1500/mm3
• Hemoglobin 8g/dl (blood transfusion is allowed to correct hemoglobin level).
• PLT ≥ 75,000/mm 3
• Total bilirubin ≤ 2 x upper normal limit (UNL)
• Serum ALT ≤ 5 x UNL
• Serum creatinine ≤ 2 mg/dL
• Serum albumin ≥ 2.5 g/dL
• No known history of brain or leptomeningeal metastasis.
• ≥ 18 years of age.
• Estimated life expectancy ≥ 24 weeks.

You may not qualify if:

• Patients who have not had at least 1 or more than 3 previous lines of treatment for metastatic or recurrent NPC
• Prior BORTEZOMIB therapy
• Immunotherapy ≤ 4 weeks have elapsed prior to study entry
• Biologic therapy ≤ 4 weeks have elapsed prior to study entry
• Radiation therapy ≤ 4 weeks have elapsed prior to study entry
• Major surgery, or significant traumatic injury ≤3 weeks prior to study entry
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
• Evidence of CNS involvement
• Presence of \> grade 1 sensory peripheral neuropathy of any etiology OR grade 1 with neuropathic pain of any etiology.
• Patients with significant local symptoms from metastases which is amenable to radiotherapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BORTEZOMIB.
• History of other malignancy ≤ 3 years prior to study entry, except for adequately treated basal cell, squamous cell skin cancer or cervical intraepithelial neoplasia.
• Uncontrolled intercurrent illness
• Patients who are pregnant or breast feeding (Sexually active men and women of childbearing potential must use contraception during course of therapy and within 3 months of completion of trial) Participation in another clinical trial involving therapeutic intervention within 4 weeks of enrollment.
• Known history of HIV

Sponsors & Collaborators

• Johns Hopkins University: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (3)

Chinese University of Hong Kong

Hong Kong, China

Location

Johns Hopkin Singapore International Medical Center

Singapore, Singapore

Location

National University Hospital of Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wen-son Hsieh, M.D.

  Johns Hopkins Singapore-International Medical Center

  STUDY CHAIR

• Brigette Ma, M.D.

  Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 23, 2006
• Last Updated: May 18, 2020

Record last verified: 2019-05

Locations

CN (1); SG (2)