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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00367718
• Other study ID #: CTRG-NP04/23/06
• Status: Withdrawn
• Phase: Phase 2

Study information

• Verified date: May 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong
Singapore	Johns Hopkin Singapore International Medical Center	Singapore
Singapore	National University Hospital of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Janssen-Cilag Ltd.

Countries where clinical trial is conducted

China,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy based on response of measurable disease		duration of study (4 -6 months)
Secondary	EBV viral load		duration of study (4 -6 months)
Secondary	toxicities		duration of study (4 -6 months)
Secondary	molecular characterization of EBV in Plasma		duration of study (4 -6 months)