- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367718
Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
May 14, 2020 updated by: Johns Hopkins University
A Phase II Trial of VELCADE in Patients With Metastatic or Locally Recurrent Nasopharyngeal Carcinoma
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy based on response of measurable disease
Time Frame: duration of study (4 -6 months)
|
duration of study (4 -6 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
EBV viral load
Time Frame: duration of study (4 -6 months)
|
duration of study (4 -6 months)
|
toxicities
Time Frame: duration of study (4 -6 months)
|
duration of study (4 -6 months)
|
molecular characterization of EBV in Plasma
Time Frame: duration of study (4 -6 months)
|
duration of study (4 -6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Wen-son Hsieh, M.D., Johns Hopkins Singapore-International Medical Center
- Study Chair: Brigette Ma, M.D., Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 21, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 23, 2006
Study Record Updates
Last Update Posted (Actual)
May 18, 2020
Last Update Submitted That Met QC Criteria
May 14, 2020
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- CTRG-NP04/23/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
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National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal...United States, Canada
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Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
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Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
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Gustave Roussy, Cancer Campus, Grand ParisUnknownLOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNTFrance
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