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

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02607332

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Paclitaxel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Paclitaxel

paclitaxel 80mg/m2/day on a Cycle1Day1, Cycle1Day8,Cycle1Day15 off 1 week schedule

Drug: Paclitaxel

Outcome Measures

Primary Outcome Measures

Disease control rate [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.