NCT01641783

Brief Summary

Gastric cancer remains one of the major causes of cancer deaths around the world,especially in Asia. For advanced gastric cancer,even if treated with chemotherapy,the prognosis is still poor, so the investigators urgently need an effective strategy to treat advanced gastric cancer, however, there was no recommended First-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound (Nab) Paclitaxel (Abraxane，ABI-007) with high effectiveness and low toxicity had been approved in breast cancer as first-line chemotherapy in many countries. The investigator then initiated a prospective phase II clinical trial with Nab-Paclitaxel plus Capecitabine as the first-line treatment in advanced gastric cancer to observe the efficacy and safety.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

July 11, 2012

Last Update Submit

July 13, 2012

Conditions

Gastric Adenocarcinoma

Keywords

advancedpaclitaxelcapecitabinefirst line therapy

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    the follow-up visit of PFS will be performed every 6 weeks

    1 year

Secondary Outcomes (3)

  • objective response rate

    6 weeks

  • overall survival of participants

    2 years

  • biomarkers

    6 weeks

Study Arms (1)

nanoparticle Albumin-bound paclitaxel

EXPERIMENTAL

evaluate one dose level of nab-paclitaxel:125mg/m2

Drug: nanoparticle Albumin-Bound paclitaxel

Interventions

nanoparticle Albumin-Bound paclitaxelDRUG

nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv

Also known as: ABI-007
nanoparticle Albumin-bound paclitaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent form;
  • histologically or cytologically confirmed gastric cancer;
  • Age 18-75 years;
  • Advanced or recurrent, metastatic disease;
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
  • Life expectancy of at least 12 weeks;
  • At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors );
  • no prior history of chemotherapy or beyond 6 months after the end of systemic adjuvant treatment;
  • Haematopoietic status:
  • Absolute neutrophil count \> 1.5 x 109/L;
  • Platelet count \> 90 x 109/L;
  • Hemoglobin at least 90g/l;
  • Hepatic status:
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN);
  • AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver metastasis);
  • +5 more criteria

You may not qualify if:

  • peripheral neuropathy of grade 2 or greater;
  • symptomatic brain metastasis;
  • known history of uncontrolled or symptomatic angina;
  • clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
  • dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
  • active or uncontrolled infection;
  • pregnant or lactating women;
  • dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine
  • unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

TaxesAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Yanqiao Zhang, M.D.

    Harbin Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqiao Zhang, M.D.

CONTACT

86-0451-86298222yanqiaozhang@126.com

Ming yang, Master

CONTACT

86-0451-86298281yangming_0517@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 17, 2012

Record last verified: 2012-07