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

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ClinicalTrials.gov Identifier: NCT00367718
Recruitment Status : Unknown
Verified August 2006 by Johns Hopkins University.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2006
Last Update Posted : August 23, 2006
Janssen-Cilag Ltd.
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Velcade Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib
U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy based on response of measurable disease

Secondary Outcome Measures :
  1. EBV viral load
  2. toxicities
  3. Molecular characterization of EBV in plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.
  • For sexually active women of childbearing potential, negative pregnancy test within 21 days of enrolling on trial.
  • must be able to give informed written consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367718

Contact: Carol Loo (65) 6772-4619 Carol_LOO@nuh.com.sg
Contact: Yoke Fong Lai (65) 68802215 yokefong@bms.jhmi.edu

Chinese University of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Brigette Ma, M.D.       Brigette@clo.cuhk.edu.hk   
Principal Investigator: Brigette Ma, M.D.         
Johns Hopkin Singapore International Medical Center
Singapore, Singapore
National University Hospital of Singapore Recruiting
Singapore, Singapore
Contact: Boon Cher Goh, M.D.       GohBC@nuh.com.sg   
Principal Investigator: Boon Cher, M.D.         
Sponsors and Collaborators
Johns Hopkins University
Janssen-Cilag Ltd.
Study Chair: Wen-son Hsieh, M.D. Johns Hopkins Singapore-International Medical Center
Study Chair: Brigette Ma, M.D. Chinese University of Hong Kong

ClinicalTrials.gov Identifier: NCT00367718     History of Changes
Other Study ID Numbers: CTRG-NP04/23/06
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: August 23, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents