Status:
WITHDRAWN
Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the overall response rate of Genexol-PM compared with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in anthracycline-pretreated patients w...
Detailed Description
This is a prospective, two-armed, parallel group, randomized phase II study for the evaluation of Genexol-PM and paclitaxel. Up to 42 eligible patients will be enrolled in each treatment arm (a total ...
Eligibility Criteria
Inclusion
- Histologically or cytologically diagnosed stage IV or recurrent breast cancer patients according to American Joint Committee on Cancer (AJCC 6th ed.)
- Prior chemotherapy at least one anthracycline-containing regimen, in either adjuvant or metastatic setting is requested.
- Previous hormonal therapy in adjuvant setting is allowed.
- Previous adjuvant taxane chemotherapy in an adjuvant setting is allowed, if taxane-free interval is more than 12 months
- previous chemotherapy for metastatic disease is not allowed except for the regimen including anthracycline.
- Previous chemotherapy including taxane for metastatic disease is not allowed.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy or chemotherapy for at least 4 weeks before the enrollment in therapy.
- Major surgery other than biopsy within the past two weeks.
- At least 18 years old
- Performance status of 0, 1 and 2 on the ECOG criteria.
- Disease status must be that of measurable disease defined as RECIST:
- Lesions that can be accurately measured in at least one dimension \> 10 mm with chest x-ray, spiral CT scan, MRI, or physical examination
- Estimated life expectancy of at least 12 weeks.
- Patient compliance that allow adequate follow-up.
- Adequate major organ function including the following:
- ①Hematologic function: WBC ³ 3,000/mm3 or absolute neutrophil count (ANC) ³ 1,500/mm3, platelet count ³ 100,000/mm3
- ②Hepatic function: bilirubin 1.5 x UNL , AST/ALT levels 2.5 x UNL
- ③Renal function: serum creatinine 1.5mg/dL
- Grade of baseline neuropathy should not be more than grade 1 by NCI CTC v.3.0
- Patients should sign an informed consent
- women of childbearing age should use non-hormonal contraceptive method.
Exclusion
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
- Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
- Psychiatric disorder that would preclude compliance.
- uncontrolled CNS disease (eligible if the CNS disease is controlled with radiotherapy or corticosteroid)
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01169870
Start Date
July 1 2007
End Date
October 1 2008
Last Update
January 4 2012
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