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An Effective and Compliance Regimen of Paclitaxel Plus Cisplatin to Treat Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00270569
First received: December 26, 2005
Last updated: February 6, 2009
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: PhyxolTM, Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Weekly Low-Dose Paclitaxel Plus 24-Hour Infusion of Cisplatin as First-Line Chemotherapy for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 43
Study Start Date: October 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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.

The eligibility criteria include (1) women with metastatic breast cancer; (2) measurable disease; (3) acceptable organ function reserves. The ineligibility criteria include (1) brain or leptomeningeal metastases; (2) previous chemotherapy for metastatic breast cancer. The study consists of two stages. All eligible patients will receive stage I (low-dose) regimen: paclitaxel, 50 mg/m2 1-hour iv infusion on days 1, 8 and 15, and cisplatin, 40 mg/m2 24-hour iv infusion on days 1 and 8. The treatment cycle will be repeated every 4 weeks. The first tumor response assessment will be done after 2 cycles of protocol treatment. Patients with complete response (CR) will receive at least 2 more cycles of low-dose regimen after documentation of CR. Patients with partial response (PR) and patients with stable disease (SD) who have minor tumor response or improvement of general condition will continue to receive the low-dose regimen. Patients with SD but no evident clinical benefit and patients with progressive disease (PD) will be shifted to stage II (conventional-dose) regimen: paclitaxel, 80 mg/m2 1-hour intravenous infusion on days 1, 8 and 15, and cisplatin, 40 mg/m2 24-hour intravenous infusion on days 1 and 8, every 4 weeks. Tumor assessment will then be evaluated after every 2 cycles of protocol treatment. For patients who continue low-dose regimen, those with CR will receive at least 2 more cycles of protocol treatment. Patients with a maximal response of PR or SD may either continue the low-dose regimen until PD or prohibitive toxicity develops or change to the conventional-dose regimen, at the discretion of the attending physicians. Patients with PD should change to the conventional-dose regimen. For patients who have shifted to conventional-dose regimen, those with CR will receive at least 2 more cycles of protocol treatment. Patients with PR will continue protocol treatment until disease progresses or prohibitive toxicity develops. Patients with SD may continue protocol treatment or change to salvage therapy. Patients with PD should stop protocol treatment and change to salvage therapy.

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. If 4 or more objective responses (CR+PR) are documented in the first 13 patients, the study will go on to the second stage to enroll a total of 43 patients. The P0, P1,are 20%, 40%, 0.05, and 0.2, respectively. Assuming a dropout rate of 10%, 15 patients will be accrued in the first stage and 33 in the second stage. Estimated time for patient accrual is 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Women with histologically proven breast cancer and clinical evidence of distant metastasis. (AJCC staging, 2002; see Appendix I)
  • 2.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 × 20 mm in size.
  • 3.Age must be older than 18 and younger than 75 year-old.
  • 4.Karnofsky performance status 70%. (see Appendix)
  • 5.Adequate bone marrow reserves, defined as white blood cell(WBC)4,000/l, absolute neutrophil count (ANC) 1,500/l, platelet 100,000/l.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270569

Contacts
Contact: Kun Huei Yeh, Ph.D. 886-2-89667000 ext 1611 khyeh@mail.femh.org.tw

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Ban-Ciao, Taiwan, 220
Contact: Kun Huei Yeh, Ph.D.    886-2-89667000 ext 1611    khyeh@mail.femh.org.tw   
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Kun Huei Yeh, Ph.D. Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00270569     History of Changes
Other Study ID Numbers: FEMH-94012
Study First Received: December 26, 2005
Last Updated: February 6, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014