NCT02251951

Brief Summary

The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

6 active sites

Status
completed

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

September 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

2.7 years

First QC Date

July 5, 2014

Last Update Submit

October 7, 2015

Conditions

Stomach and Gastro-Esophageal Junction (GEJ) Cancer

Keywords

CancerStomachGastro-Esophageal JunctionSalvage treatmentNab-paclitaxel

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response

    Disease evaluation every 8 weeks up to 108 weeks

Secondary Outcomes (4)

  • Disease control rate

    Disease evaluation every 8 weeks up to 108 weeks

  • Progression Free Survival

    Up to 108 weeks

  • Overall Survival

    Up to 108 weeks

  • Number of Participants with Adverse Events

    Every two weeks up to 24 weeks

Study Arms (1)

nab-Paclitaxel

EXPERIMENTAL

Abraxane

Drug: nab-Paclitaxel

Interventions

nab-PaclitaxelDRUG

Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)

Also known as: Abraxane
nab-Paclitaxel

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Disease progression after treatment with the DCF regimen
  • Assessable target lesion(s) as defined by RECIST criteria
  • ECOG performance status ≤ 1
  • Estimated life expectancy more than 3 months
  • Serum bilirubin less than 1.5 times the upper normal limit
  • Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
  • Creatinine Clearance ≥50 ml/min
  • Neutrophil count more than 1.5x 109 /L
  • Platelet count more than 100x 109 /L
  • Hemoglobin more than 8g/dL
  • Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.

You may not qualify if:

  • Gastrointestinal bleeding
  • Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
  • CNS metastases
  • Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
  • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
  • Known hypersensitivity reaction to the component of the treatment
  • Active infection or malnutrition or bowel obstruction
  • Legal incapacity or limited legal capacity
  • Definite contraindications for the use of corticosteroids
  • History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • Chronic inflammation of the bowel
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
  • Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
  • Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Heraklion, Crete, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Air Forces Military Hospital of Athens Athens, Greece

Athens, Greece

Location

SOTIRIA Hospital, Medical Oncology Department

Athens, Greece

Location

"Ag. Georgios" General Hospital of Chania

Chania, Greece

Location

"PAPAGEORGIOY" General Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • John Souglakos, MD

    University Hospital of Herklion

    PRINCIPAL INVESTIGATOR

  • Vassilis Georgoulias, MD

    University Hospital of Heraklion

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2014

First Posted

September 29, 2014

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

GR(6)