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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00367718
First received: August 21, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention Phase
Nasopharyngeal Carcinoma
Drug: Velcade
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Efficacy based on response of measurable disease

Secondary Outcome Measures:
  • EBV viral load
  • toxicities
  • Molecular characterization of EBV in plasma

Estimated Enrollment: 25
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00367718

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

Locations
China
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.         
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.         
Johns Hopkin Singapore International Medical Center
Singapore, Singapore
Sponsors and Collaborators
Johns Hopkins University
Janssen-Cilag Ltd.
Investigators
Study Chair: Wen-son Hsieh, M.D. Johns Hopkins Singapore-International Medical Center
Study Chair: Brigette Ma, M.D. Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00367718     History of Changes
Other Study ID Numbers: CTRG-NP04/23/06
Study First Received: August 21, 2006
Last Updated: August 21, 2006
Health Authority: United States: Institutional Review Board
Singapore: Institutional Review Board
Singapore: Health Services Authority

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Carcinoma
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014