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A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer


Phase 1/Phase 2
19 Years
N/A
Open (Enrolling)
Both
Advanced Metastatic Gastric Cancer, Recurrent Gastric Cancer

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Trial Information

A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer


Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a
week, total 6 times per cycle (day 1,2,8,9,15 and 16).


Inclusion Criteria:



1. Patients must histologically or cytologically be diagnosed to have an advanced solid
cancer. (phaseI)

2. Advanced/metastatic/recurred gastric cancer(PhaseII)

3. ECOG performance status ≤ 2

4. Patients have proper bone marrow, kidney, liver function and patients do not have
remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3;
Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the
upper limit of normal; Total bilirubin ≤2.0mg/dL *AST/ALT/ALP ≤ 3 X the upper limit
of normal but <5 if liver or bone metastasis is present

Exclusion Criteria:

1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic
disorders, metastasis to CNS or ileus (patients requiring non-oral administration of
anti-biotics to treat active bacterial infection are nor eligible, but patients can
participate in the trial after complete eradication or control of the infection)

2. Patients who have received bone marrow transplant or are to receive bone marrow
transplant.

3. Patients who had the medical history of atrial or ventricular arrhythmia or
congestive heart failure or received medical treatment for myocardial infarction
within 6 months.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity evaluation (safety evaluation)

Outcome Description:

Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).

Outcome Time Frame:

DLT will be assessed on 28days of 1 cycle

Safety Issue:

Yes

Principal Investigator

Yung-Jue Bang, MD. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

HM-OXL-201

NCT ID:

NCT01491217

Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Advanced Metastatic Gastric Cancer
  • Recurrent Gastric Cancer
  • Oraxol®
  • oral paclitaxel
  • paclitaxel
  • HM30181A
  • MTD
  • DLT
  • RD
  • Stomach Neoplasms

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