Breast CancerPhase 2NCT00154882
Paclitaxel (Phyxol) and Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
A Phase 2 study testing Paclitaxel (Phyxol) , Cisplatin in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel (Phyxol) , Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2003to Jul 2007
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically proven breast cancer and clinical evidence of distant metastasis
- The index lesions should be at least 20 mm × 20 mm in size
- Age must be older than 18 and younger than 75 year-old
- Karnofsky performance status > 70%
- Adequate bone marrow reserves, defined as white blood cell (WBC) > 4,000, absolute neutrophil count (ANC) > 1,500, platelet > 100,000
- Liver transaminases < 3 times upper normal limit if no liver metastasis and 5 times upper normal limit if liver metastasis is present; total bilirubin < 2 mg/dl; serum creatinine < 1.5 mg/dl
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- No prior chemotherapy for metastatic disease. Previous chemotherapy as adjuvant treatment is acceptable, if the adjuvant chemotherapy has been completed at least 6 months before entry into in this study
- If the patients have received hormonal therapy for metastatic disease, there must be definite evidence of disease progression under the hormonal therapy, and hormonal therapy should be discontinued before entry into this study
- Previous or concurrent radiotherapy is acceptable if the area of radiation does not involve the site of the index tumor lesions
- Patients of childbearing age should have effective contraception during the study period
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.
Who cannot join
- Patients who are receiving concurrent hormonal or cytotoxic therapy or other experimental therapy. Concurrent therapy with other biological agents, such as Trastuzumab (Herceptin), is not allowed
- Patients who refuse port-A catheter implantation
- Patients who have received taxane (paclitaxel or docetaxel) or cisplatin as adjuvant chemotherapy
- Patients with brain or leptomeningeal metastases
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy
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- Life expectancy less than 2 months
- Pregnant or nursing patients may not participate. Patients with reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Oncology , National Taiwan University Hospital
Taipei
Yen-Shen Lu, M.D., 886-2-23123456 ext. 7009, yslu@ha.mc.ntu.edu.tw
Sung-Hsin Kuo, M.D.
About this study
Official title: Weekly Low-dose Paclitaxel (Phyxol) Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.
Read the detailed description
Breast cancer is one of the leading causes of cancer death for women in Taiwan. We have recently demonstrated that combination of paclitaxel and cisplatin, at conventional doses, is highly effective in the treatment of breast cancer. However, the acute and cumulative toxicities of paclitaxel have been troublesome to a significant portion of the patients. Several lines of evidence suggested that weekly paclitaxel, at a much lower dose range of 40 to 50 mg/m2 per week, may be as effective as that of the conventional doses of paclitaxel (80 to 90 mg/m2 per week) for patients with metastatic ovarian and lung cancers. The low-dose regimen of paclitaxel may significantly improve the compliance of the patients. This open-label phase II trial is designed to test this hypothesis.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel (Phyxol) , Cisplatin
- Keywords
- Breast Cancer, First-line
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel (Phyxol) , CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Paclitaxel (Phyxol) , Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen.
Measured: 2003~2008
Secondary outcomes (1)
The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.
Measured: 2003~2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJul 2007 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yen-Shen Lu, M.D., Principal investigator, Department of Oncology , National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154882
- Sponsor's protocol ID
- 920705
- Status last verified
- Jul 2005
- First submitted
- 8 Sep 2005
- Last updated
- 21 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Low-dose Paclitaxel (Phyxol) Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00154882
- Acronym / sponsor ID
- 920705
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, First-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Jul 2007 (estimated)
- First posted
- 12 Sep 2005 (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 primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.
Detailed description
Breast cancer is one of the leading causes of cancer death for women in Taiwan. We have recently demonstrated that combination of paclitaxel and cisplatin, at conventional doses, is highly effective in the treatment of breast cancer. However, the acute and cumulative toxicities of paclitaxel have been troublesome to a significant portion of the patients. Several lines of evidence suggested that weekly paclitaxel, at a much lower dose range of 40 to 50 mg/m2 per week, may be as effective as that of the conventional doses of paclitaxel (80 to 90 mg/m2 per week) for patients with metastatic ovarian and lung cancers. The low-dose regimen of paclitaxel may significantly improve the compliance of the patients. This open-label phase II trial is designed to test this hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paclitaxel (Phyxol) , Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women with histologically proven breast cancer and clinical evidence of distant metastasis
- The index lesions should be at least 20 mm × 20 mm in size
- Age must be older than 18 and younger than 75 year-old
- Karnofsky performance status > 70%
- Adequate bone marrow reserves, defined as white blood cell (WBC) > 4,000, absolute neutrophil count (ANC) > 1,500, platelet > 100,000
Key exclusion criteria (9 listed)
- Patients who are receiving concurrent hormonal or cytotoxic therapy or other experimental therapy. Concurrent therapy with other biological agents, such as Trastuzumab (Herceptin), is not allowed
- Patients who refuse port-A catheter implantation
- Patients who have received taxane (paclitaxel or docetaxel) or cisplatin as adjuvant chemotherapy
- Patients with brain or leptomeningeal metastases
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry
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 |
|---|---|---|
| Paclitaxel (Phyxol) , Cisplatin | Drug | A |
Primary outcome
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen.
Time frame: 2003~2008
1 secondary outcome
The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.
Time frame: 2003~2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2010.
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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.
Yen-Shen Lu, M.D. principal investigator
Department of Oncology , National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel (Phyxol) , Cisplatin in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiun Hsu, M.D., Ph.D. (886-2-23123456 ext. 7009, chiunhsu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. (time frame: 2003~2008). 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 21 Jan 2010.