Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib

January 6, 2020 updated by: Yoon-Koo Kang, Asan Medical Center

A Trial of Paclitaxel in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors (GIST) After Failure to Imatinib and Sunitinib

With discovery of KIT mutations and the advent of KIT tyrosine kinase inhibitor imatinib (GlivecTM, Novartis), there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib (SuteneTM, Pfizer) showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after the first-line imatinib and the second-line sunitinib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • 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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 years or older
  • Histologically confirmed metastatic and/or advanced GIST with CD117(cluster of differentiation 117)(+), DOG-1(+), or mutation in KIT or PDGFRα gene(Platelet Derived Growth Factor Receptor)
  • Failed (progressed and/or intolerable) after prior treatments for GIST, including at least both imatinib and sunitinib .
  • Eastern Cooperative Oncology Group performance status of 0~2
  • Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-Common Toxicity Criteria for Adverse Effects version 3.0
  • At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors version 1.0

  • Adequate bone marrow, hepatic, renal, and other organ functions

    • Neutrophil > 1,500/mm3
    • Platelet > 100,000/mm3
    • Hemoglobin > 8.0 g/dL
    • Total bilirubin < 1.5 x upper limit of normal (ULN)
    • Aspartate aminotransferase /Alanine transferase< 2.5 x ULN (or < 5 x ULM in case of liver metastases)
    • Creatinine < 1.5 x ULN
  • Life expectancy > 12 weeks
  • Washout period of previous TKIs(Tyrosine Kinase Inhibitor) or chemotherapy for more than 4 times the half life.
  • Provision of a signed written informed consent

Exclusion Criteria:

  • Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
  • have the presence of cardiac disease,including a myocardial infarction within 6 months prior to study entry,Clinically significant cardiac disease (New York Heart Association, Class III or IV) or severe unstable angina pectoris, stroke or transient ischemic attack, Arrhythmia in need of treatment
  • Uncontrolled infection
  • Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
  • Acute and chronic liver disease and all chronic liver impairment.(Patients with stable and chronic viral hepatitis are eligible are acceptable)
  • Uncontrolled gastrointestinal toxicities with toxicity greater than NCI Common Toxicity Criteria for Adverse Effects grade 2
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality.
  • The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleeding event.
  • Major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy.
  • Known diagnosis of HIV infection .
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention.
  • Patients with brain metastases as assessed by radiologic imaging
  • Alcohol or substance abuse disorder.

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
Intervention / Treatment
Experimental: Paclitaxel
paclitaxel 80mg/m2/day on a Cycle1Day1, Cycle1Day8,Cycle1Day15 off 1 week schedule
Drug: Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease control rate
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

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

Sponsor

Asan Medical Center

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

November 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC1501

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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