Breast CancerPhase 2NCT01169870
Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
A Phase 2 study testing Genexol-PM and Paclitaxel in people with Breast Cancer, run by National Cancer Center, Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Genexol-PM and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
About this study
Official title: A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Genexol-PM, Paclitaxel
- Keywords
- metastatic
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genexol-PMDrug
Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.
PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Genexol-PM | Experimental | 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. Receives: Drug: Genexol-PM |
| Paclitaxel | Active comparator | Paclitaxel 175mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 3 hour on day 1, every 3 week cycle. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 21Aug2007~22Aug2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionOct 2008
Why it stopped: withdrawn studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jungsil Ro, National Cancer Center, Korea
- Investigators
- Jungsil Ro, Ph,D, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169870
- Sponsor's protocol ID
- NCCCTS-07-278
- Status last verified
- Jan 2012
- First submitted
- 8 Feb 2010
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Genexol-PM vs Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01169870
- Acronym / sponsor ID
- NCCCTS-07-278
- Conditions
- Breast Cancer
- Keywords
- metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genexol-PM | Experimental | Drug: Genexol-PMGenexol-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 | Active comparator | Drug: PaclitaxelPaclitaxel 175mg/m2, diluted with 500ml of 5% dextrose or normal saline, intravenous infusion over 3 hour on day 1, every 3 week cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genexol-PMTreatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles. | Drug | Genexol-PM |
| Paclitaxel | Drug | Paclitaxel |
Primary outcome
overall response rate
Time frame: 21Aug2007~22Aug2008
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jungsil Ro, Ph,D principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genexol-PM and Paclitaxel in people with Breast Cancer, run by National Cancer Center, Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 21Aug2007~22Aug2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2012.