Clinical trial NCT00367718: Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Official title: A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2006-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy based on response of measurable disease
timeFrame: duration of study (4 -6 months)
Secondary outcomes:
measure: EBV viral load
timeFrame: duration of study (4 -6 months)
measure: toxicities
timeFrame: duration of study (4 -6 months)
measure: molecular characterization of EBV in Plasma
timeFrame: duration of study (4 -6 months)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
city: Singapore
country: Singapore
facility: Johns Hopkin Singapore International Medical Center
city: Singapore
country: Singapore
facility: National University Hospital of Singapore
Study officials:
affiliation: Johns Hopkins Singapore-International Medical Center
name: Wen-son Hsieh, M.D.
role: STUDY_CHAIR
affiliation: Chinese University of Hong Kong
name: Brigette Ma, M.D.
role: STUDY_CHAIR
References: