Back to resultsGenexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Genexol-PM
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastatic
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Genexol-PM
Paclitaxel
Arm Description
Genexol-PM 300mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 1 hour on day 1, every 3 week cycle.
Paclitaxel 175mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 3 hour on day 1, every 3 week cycle.
Outcomes
Primary Outcome Measures
overall response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01169870
First Posted
February 8, 2010
Last Updated
January 1, 2012
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01169870
Brief Title
Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
Official Title
A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
withdrawn studies
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 with metastatic breast cancer.
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 of 84) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). They will be stratified by ER status(positive v negative), performance(ECOG 0 or 1 v 2), and prior adjuvant taxane (no v yes) The treatment will be continued up to 6 cycles, or will be discontinued before 6th cycle iin case of disease progression, unacceptable toxicity, or patient withdrawal. After discontinuation of study therapy, patients will proceed to the post-therapy follow-up phase of the study.
Patients may be enrolled in the study if they have documented measurable disease. Response will be documented by physical examination prior to each treatment cycle and a CT scan every two cycles or if disease progression is suspected. Responses will be assessed unidimensionally according to the RECIST. All partial or complete responses require confirmation with a second evaluation at least 4 weeks following the first documentation of response.
All toxicities encountered during the study will be evaluated before each cycle using the NCI CTC (National Cancer Institute Common Toxicity Criteria) version 3.0 scale. For peripheral neuropathy, the scale in Table 4 will be used to determine dose adjustments. Life-threatening toxicities should be reported immediately to the Study Chairman.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genexol-PM
Arm Type
Experimental
Arm Description
Genexol-PM 300mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 1 hour on day 1, every 3 week cycle.
Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
Paclitaxel 175mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 3 hour on day 1, every 3 week cycle.
Intervention Type
Drug
Intervention Name(s)
Genexol-PM
Intervention Description
Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
overall response rate
Time Frame
21Aug2007~22Aug2008
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jungsil Ro, Ph,D
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
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