Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer

October 7, 2015 updated by: Hellenic Oncology Research Group

A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • Air Forces Military Hospital of Athens Athens, Greece
      • Athens, Greece
        • SOTIRIA Hospital, Medical Oncology Department
      • Chania, Greece
        • "Ag. Georgios" General Hospital of Chania
      • Thessaloniki, Greece
        • "PAPAGEORGIOY" General Hospital of Thessaloniki
    • Crete
      • Heraklion, Crete, Greece
        • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: nab-Paclitaxel
Abraxane
Drug: nab-Paclitaxel
Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)
Other Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Disease evaluation every 8 weeks up to 108 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: Disease evaluation every 8 weeks up to 108 weeks
Documented disease control 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
Progression Free Survival
Time Frame: Up to 108 weeks
From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks
Up to 108 weeks
Overall Survival
Time Frame: Up to 108 weeks
From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks
Up to 108 weeks
Number of Participants with Adverse Events
Time Frame: Every two weeks up to 24 weeks
Every two weeks up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hellenic Oncology Research Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Souglakos, MD, University Hospital of Herklion
  • Principal Investigator: Vassilis Georgoulias, MD, University Hospital of Heraklion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT/12.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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