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

Phase 2
18 Years
75 Years
Not Enrolling
Nasopharyngeal Carcinoma

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy based on response of measurable disease

Principal Investigator

Wen-son Hsieh, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Johns Hopkins Singapore-International Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms