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

January 25, 2014 updated by: Li Zhang, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center, Sun Yat-sen University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-day regimen
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
Experimental: 2-day regimen
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
Experimental: 3-day regimen
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: 24 months
24 months
Number of Participants with Adverse Events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 22, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 25, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABXDDP20101224

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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