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

NCT ID: NCT00367718

Last Updated: 2020-05-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Velcade

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen-son Hsieh, M.D.

Role: STUDY_CHAIR

Johns Hopkins Singapore-International Medical Center

Brigette Ma, M.D.

Role: STUDY_CHAIR

Chinese University of Hong Kong

Locations

Chinese University of Hong Kong

Hong Kong, , China

Johns Hopkin Singapore International Medical Center

Singapore, , Singapore

National University Hospital of Singapore

Singapore, , Singapore

Countries

China; Singapore

Other Identifiers

CTRG-NP04/23/06

Identifier Type: -

Identifier Source: org_study_id