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Nasopharyngeal NeoplasmsPhase 1/2ABX-DDP-DoseNCT01735409

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

A Phase 1/2 study testing ABX + DDP in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
ABX + DDP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
Nov 2012to Jun 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
ABX + DDP
Keywords
Advanced Nasopharyngeal Carcinoma, Abraxane, Cisplatin, Dose
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABX + DDPDrug

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

  • ABX + DDPDrug

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

  • ABX + DDPDrug

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

Study groups in NCT01735409
Study groupRoleWhat they receive
1-day regimenExperimentalABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
Receives: Drug: ABX + DDP
2-day regimenExperimentalABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
Receives: Drug: ABX + DDP
3-day regimenExperimentalABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
Receives: Drug: ABX + DDP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    Measured: 24 months

Secondary outcomes (2)

  1. Progression free survival (PFS)

    Measured: 24 months

  2. Number of Participants with Adverse Events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMar 2014 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01735409
Sponsor's protocol ID
ABXDDP20101224
Acronym
ABX-DDP-Dose
Status last verified
Jan 2014
First submitted
22 Nov 2012
Last updated
28 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27411683

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABX + DDP in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01735409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.

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