Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma (ABX-DDP-Dose)
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ClinicalTrials.gov Identifier: NCT01735409 |
Recruitment Status
: Unknown
Verified January 2014 by Li Zhang, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted
: November 28, 2012
Last Update Posted
: January 28, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Neoplasms | Drug: ABX + DDP | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 69 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | June 2014 |

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
|
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
|
- Objective response rate (ORR) [ Time Frame: 24 months ]
- Progression free survival (PFS) [ Time Frame: 24 months ]
- Number of Participants with Adverse Events [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735409
China, Guangdong | |
Cancer Center, Sun Yat-sen University | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | Li Zhang, MD | Sun Yat-sen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Li Zhang, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01735409 History of Changes |
Other Study ID Numbers: |
ABXDDP20101224 |
First Posted: | November 28, 2012 Key Record Dates |
Last Update Posted: | January 28, 2014 |
Last Verified: | January 2014 |
Keywords provided by Li Zhang, Sun Yat-sen University:
Advanced Nasopharyngeal Carcinoma Abraxane Cisplatin Dose |
Additional relevant MeSH terms:
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin Albumin-Bound Paclitaxel Antineoplastic Agents |