NCT00270569

Brief 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. Simon's optimal two-stage design will be used to determine the patient number.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

February 9, 2009

Status Verified

August 1, 2005

Enrollment Period

1.3 years

First QC Date

December 26, 2005

Last Update Submit

February 6, 2009

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to determine the tumor response of weekly low-dose paclitaxel plus 24-hour infusion of cisplatin chemotherapy for patients with metastatic breast cancer.

Secondary Outcomes (4)

  • Toxicities of weekly low- or conventional-dose paclitaxel plus 24-hour infusion of cisplatin.

  • The patients'quality of life as evaluated by questionnaire interview.

  • Progression-free survival.

  • Overall survival.

Interventions

PhyxolTM, CisplatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with histologically proven breast cancer and clinical evidence of distant metastasis. (AJCC staging, 2002; see Appendix I)
  • Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography (CT) scan). The index lesions should be at least 20 mm Ă— 20 mm in size.
  • Age must be older than 18 and younger than 75 year-old.
  • Karnofsky performance status 70%. (see Appendix)
  • Adequate bone marrow reserves, defined as white blood cell(WBC)4,000/l, absolute neutrophil count (ANC) 1,500/l, platelet 100,000/l.
  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Ban-Ciao, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Kun Huei Yeh, Ph.D.

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Huei Yeh, Ph.D.

CONTACT

886-2-89667000khyeh@mail.femh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2005

First Posted

December 28, 2005

Study Start

October 1, 2005

Primary Completion

February 1, 2007

Last Updated

February 9, 2009

Record last verified: 2005-08

Locations

TW(1)