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

NCT01735409 | Unknown Phase 1 DMC

• 1 other identifier: ABXDDP20101224
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Neoplasms

Keywords

Advanced Nasopharyngeal Carcinoma; Abraxane; Cisplatin; Dose

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  24 months

Secondary Outcomes (2)

• Progression free survival (PFS)

  24 months

• Number of Participants with Adverse Events

  24 months

Study Arms (3)

1-day regimen

EXPERIMENTAL

ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1

Drug: ABX + DDP

2-day regimen

EXPERIMENTAL

ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1

Drug: ABX + DDP

3-day regimen

EXPERIMENTAL

ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1

Drug: ABX + DDP

Interventions

ABX + DDP DRUG

ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1

1-day regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Huang Y, Liang W, Yang Y, Zhao L, Zhao H, Wu X, Zhao Y, Zhang Y, Zhang L. Phase I/II dose-finding study of nanoparticle albumin-bound paclitaxel (nab(R)-Paclitaxel) plus Cisplatin as Treatment for Metastatic Nasopharyngeal Carcinoma. BMC Cancer. 2016 Jul 13;16:464. doi: 10.1186/s12885-016-2517-5.

  PMID: 27411683 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

CN (1)