Clinical Trials Logo
  1. Home
  2. Nasopharyngeal Neoplasms
  3. NCT01735409

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

Nasopharyngeal Neoplasms Clinical Trial

Official title:
A Single Center Phase IIa Study of Nanoparticle Albumin-bound Paclitaxel in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01735409
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 2012
Completion date June 2014
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00577057 - Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer N/A
Completed NCT01256853 - Modified Vaccinia Ankara (MVA) Vaccine Study Phase 1
Recruiting NCT02945878 - Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma N/A
Terminated NCT02874651 - ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy Phase 2
Not yet recruiting NCT05807880 - Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Completed NCT00342147 - Family Study of Head and Neck Cancers in Taiwan
Recruiting NCT02980315 - A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application Phase 1/Phase 2
Completed NCT00565448 - Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents Phase 2
Completed NCT00630149 - Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy Phase 2
Active, not recruiting NCT03854838 - IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma. Phase 2
Completed NCT01797900 - The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT Phase 2
Completed NCT00436800 - Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT00563927 - Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0) N/A
Not yet recruiting NCT04870905 - Tisleilizumab (PD-1 Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma Phase 2
Active, not recruiting NCT02902432 - A Trial of Endostar in Patients With Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT02456506 - Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma. N/A
Completed NCT02444949 - A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma Phase 2
Completed NCT00188877 - Intensity Modulated Radiation Therapy for Head and Neck Cancer Phase 2
Terminated NCT00393224 - Defining the Clinical Utility of EBV Antibody Screening to Identify Individuals Susceptible to Nasopharyngeal Carcinoma (NPC) Within High-Risk, Multiplex NPC Families
Not yet recruiting NCT03093649 - Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma N/A