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

Johns Hopkins University

Status and phase

Withdrawn

Phase 2

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: Velcade

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00367718

CTRG-NP04/23/06

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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