Paclitaxel (Phyxol) and Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer

January 20, 2010 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Department of Oncology , National Taiwan University Hospital
        • Contact:
        • Sub-Investigator:
          • Sung-Hsin Kuo, M.D.
        • Sub-Investigator:
          • Chia-Chi Lin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with histologically proven breast cancer and clinical evidence of distant metastasis
  2. The index lesions should be at least 20 mm × 20 mm in size
  3. Age must be older than 18 and younger than 75 year-old
  4. Karnofsky performance status > 70%
  5. Adequate bone marrow reserves, defined as white blood cell (WBC) > 4,000, absolute neutrophil count (ANC) > 1,500, platelet > 100,000
  6. 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
  7. 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
  8. 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
  9. Previous or concurrent radiotherapy is acceptable if the area of radiation does not involve the site of the index tumor lesions
  10. Patients of childbearing age should have effective contraception during the study period
  11. 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.

Exclusion Criteria:

  1. 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
  2. Patients who refuse port-A catheter implantation
  3. Patients who have received taxane (paclitaxel or docetaxel) or cisplatin as adjuvant chemotherapy
  4. Patients with brain or leptomeningeal metastases
  5. Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry
  6. Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy
  7. Life expectancy less than 2 months
  8. Pregnant or nursing patients may not participate. Patients with reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  9. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Paclitaxel (Phyxol) , Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen.
Time Frame: 2003~2008
2003~2008

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.
Time Frame: 2003~2008
2003~2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yen-Shen Lu, M.D., Department of Oncology , National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Anticipated)

July 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 21, 2010

Last Update Submitted That Met QC Criteria

January 20, 2010

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Paclitaxel (Phyxol) , Cisplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe