Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, non-randomized phase IIa study to determine the tolerance and safety of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE V4.0 and RECIST 1.1 respectively.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin

Criteria

Inclusion Criteria:

• Histologically proven NPC diagnosis

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

• 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 transplants;

• 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