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A Single Center, Non-randomized Phase IIa Study of Abraxane in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Nasopharyngeal Neoplasms

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Trial Information

A Single Center, Non-randomized Phase IIa Study of Abraxane in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in
southern and southeastern China, where the incidence rate has been documented between 10 and
150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy
remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel
([Abraxane, ABX ];Celgene,Summit,NJ) is a promising new agent with more efficient entry to
the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by
cancer cells. Superior activity of ABX-based regimens without the necessity for
antianaphylactic pretreatments been shown in various solid tumors compared with the
traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of
combination of ABX and cisplatin (DDP) has not been determined in patients with advanced
NPC. In this single center, non-randomized phase IIa study, investigators seek to determine
the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an
exploratory study of its efficacy as measured by tumor response.

Inclusion Criteria:

- Histologically proven NPC diagnosis

- Patients who failed the prior standard treatment or were intolerant of standard

- Elder than 18 years old

- Performance status 0-2

- Patients previously treated with chemotherapy (those having received paclitaxel-based
regimen were not excluded)

- Subjects with at least one measurable lesion (Tumor lesions that are situated in a
previously irradiated area could not be considered measurable).

- Life expectancy over twelve weeks

- Neutrophil > 1.5X10^9/L, PLT > 100X10^9/L, Hb ≥ 90 g/l, with normal hepatic
function(AST, ALT < 2.5 x upper limit of normal , and bilirubin < 1.0 x upper limit
of normal), with normal renal function (creatinine < 1.5 x upper limit of normal or
creatinine clearance ≥ 60ml/min as calculated by the Cockcroft - Gault formula. )

- Urine pregnancy test (-) within 1 weeks before enrollment or being able to take
effective contraceptive measures during the medication and six months after
completion of the trial for fertile women.

- Being able to provide paraffin blocks or 5-7 slides of biopsy tumor tissues.

- Amenable to regular follow-up and to comply with trial requirements.

- Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria:

- History of allergy to paclitaxel or docetaxel

- Patient with central nervous system metastasis

- Patient refusing participation or signing informed consent

- Active clinically serious infections with an anticipated antibiotics treatment for
more than 4 weeks

- Patient with life threatening medical condition such as congestive heart failure,
symptomatic coronary artery disease or heart block

- Myocardial infarction that occurred within 3 months before enrollment

- Had received chemotherapy, radiotherapy or other anti-cancer therapies within 3 weeks
before enrollment

- With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity
Criteria for Adverse Events [NCI CTC] grade ≥ 2)

- Previously received post-2nd line anti-cancer therapy

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors[Ta, Tis & T1] or any cancer curatively
treated > 3 years prior to study entry.

- History of immunodeficiency , including HIV testing positive or suffering from other
acquired and congenital immunodeficiency disease, or the history of organ

- Patients receiving prior abraxane treatment during pregnancy or lactation period

- Fertile women who failed to or are reluctant to take contraceptive measures or
pregnancy test

- Men or his companion who are reluctant to take effective contraceptive measures
during the medication and six months after completion of the trial

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate (ORR)

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Li Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

August 2013

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Advanced Nasopharyngeal Carcinoma
  • Abraxane
  • Cisplatin
  • Dose
  • Neoplasms
  • Carcinoma
  • Nasopharyngeal Neoplasms