Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
Phase 2
Withdrawn
- Conditions
- Nasopharyngeal Carcinoma
- Registration Number
- NCT00367718
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy based on response of measurable disease duration of study (4 -6 months)
- Secondary Outcome Measures
Name Time Method EBV viral load duration of study (4 -6 months) toxicities duration of study (4 -6 months) molecular characterization of EBV in Plasma duration of study (4 -6 months)
Trial Locations
- Locations (3)
Chinese University of Hong Kong
🇨🇳Hong Kong, China
National University Hospital of Singapore
🇸🇬Singapore, Singapore
Johns Hopkin Singapore International Medical Center
🇸🇬Singapore, Singapore