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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01735409
First received: November 22, 2012
Last updated: January 25, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Neoplasms
Drug: ABX + DDP
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center Phase IIa Study of Nanoparticle Albumin-bound Paclitaxel in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with Adverse Events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 69
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 2-day regimen
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Drug: ABX + DDP
ABX 140 mg/m2 day 1,8 + 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 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735409

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Zhang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01735409     History of Changes
Other Study ID Numbers: ABXDDP20101224
Study First Received: November 22, 2012
Last Updated: January 25, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Advanced Nasopharyngeal Carcinoma
Abraxane
Cisplatin
Dose

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014