A Phase I/II Double-Blind, Randomized, Placebo-Control Pilot Study to Evaluate the Safety and Pharmacodynamic Activities of EW02 in Reducing Neutropenia Caused by Breast Cancer Chemotherapy
20 Years
70 Years
Both
Breast Cancer, Chemotherapy, Neutropenia
Trial Information
A Phase I/II Double-Blind, Randomized, Placebo-Control Pilot Study to Evaluate the Safety and Pharmacodynamic Activities of EW02 in Reducing Neutropenia Caused by Breast Cancer Chemotherapy
Study procedures:
This is a single-center, double-blind, placebo-controlled parallel, pilot study of oral EW02
in combination with chemotherapy, versus placebo in combination with chemotherapy in breast
cancer patients as the primary phase (Cycle 1). The chemotherapy regimen is restricted to
one of the following regimens: Doxorubicin + Cyclophosphamide (AC), or Doxorubicin+
Cyclophosphamide+5-FU (CAF) under standardized dosage. The WBC recovery time is similar
between these two chemotherapy regimens due to the facts that doxorubicin and
cyclophosphamide are overlapped and their dose in CAF is reduced. The principle investigator
has clinical experiences that the neutropenia nadir and severity caused by these two
regimens are almost the same. Nevertheless, pre-stratification by chemotherapy regimen
(stratum AC versus stratum CAF) at randomization will be implemented so that equal sample
size of two study products will be allocated under each stratum. It will involve 60
outpatients for breast cancer, who have previously demonstrated a fall unto 1,000 to
3,000/mm3 in WBC count, or unto 500 to 1,500/mm3 in ANC count, on Day 8 or Day 15, whilst on
Cycle 1.
The second phase (Cycle 2): EW02 at 700mg tid daily versus placebo group are given at the
beginning of Cycle 2 for 15 consecutive days. 60 subjects will be randomized 2:1 to two
groups in pre-stratified permuted blocks of six with four subjects assigned to Group 1
(EW02) while two subjects assigned to Group 2 (Placebo). Group 1 will receive EW02 for 15
consecutive days during the second cycle and Group 2 will receive 15 consecutive days of
Placebo.
The extension phase (Cycle 3): is designed to collect additional safety data and to ensure
all the participants will have the opportunity to receive study drug. Thus, both groups will
receive EW02 at 700mg tid/day for 15 consecutive days.
Inclusion Criteria:
1. Signed informed consent obtained prior to inclusion in study
2. Pathologically confirmed breast cancer, whose CBC has shown ever dropped unto 1,000
to 3,000/mm3 in WBC count, or unto 500 to 1,500/mm3 in ANC count, on Day 8 or Day 15,
whilst on Cycle 1 of current chemotherapy.
3. Age 20 - 70 years
4. Stage T 1-3, N 0-2, M0.
5. ECOG performance status of < 2
6. Chemotherapy regimen is restricted to one of the followings:
(1)Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2(AC X 4cycles) or (2)Cyclophosphamide
500 mg/m2 + Doxorubicin 50 mg/m2 + 5-FU 500 mg/m2 (CAF X 6 cycles) 7.Laboratory test
results within 30 days prior to study entry:
1. Hemoglobin 9.0 g/dL for men and 8.7 g/dL for women and platelet> 100,000/mm³ without
the need for current, on-going use of erythropoietin or transfusion
2. Normal liver function (GOT < 1.5 x ULN)
3. Normal kidney function (Creatinine < 1.5 x ULN) and no dialysis. 8.Negative of
mandatory pregnancy test for women subjects.
Exclusion Criteria:
1. Women under pregnancy or with positive result from mandatory pregnancy test or in
lactating; women of child-bearing potential must use adequate contraception
2. Prior systemic therapy or radiotherapy for breast cancer
3. Known hypersensitivity to bean products
4. Serious medical or psychiatric illness that, in the opinion of the principal
investigator, would interfere with the ability to adhere to study requirements.
5. History of myocardial infraction or angina.
6. Uncontrollable acute or chronic diseases, including hypertension or diabetes.
7. Second malignancy or cancer metastasis
8. HBV or HCV carrier
9. WBC below 4000 or ANC below 2000 on D1 of Cycle 1
10. Participation in investigational drug study within the past 30 days
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
% change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC,
Outcome Time Frame:
% change from Visit 5 (C2, Day 1) to Visit 7 (C2, Day 15) in WBC,
Principal Investigator
Tsu-Yi Chao, M.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tri-Service General Hospital
Authority:
Taiwan: Department of Health
Study ID:
DOH96-TD-I-111-003
NCT ID:
NCT00555516
Start Date:
November 2007
Completion Date:
June 2009
Related Keywords:
- Breast Cancer
- Chemotherapy
- Neutropenia
- Breast Cancer、 Chemotherapy、 Neutropenia、WBC
- Breast Neoplasms
- Neutropenia
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