Overview

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

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
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.