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Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006120
Recruitment Status : Unknown
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: paclitaxel Phase 2

Detailed Description:

OBJECTIVES:

  • Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel.
  • Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
  • Compare the quality of life of patients treated with these four regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no).

Patients are randomized to one of four treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on day 1.
  • Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
  • Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
  • Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.

Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to treatment and then every 8 weeks.

PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
Study Start Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer





Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven unresectable locally advanced or metastatic breast cancer

    • Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
  • At least one bidimensionally measurable lesion
  • No brain metastasis
  • No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease
  • Hormone receptor status:

    • Known hormone receptor status

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin normal

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No uncontrolled angina or arrhythmia
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease

Other:

  • No sensitive neuropathy worse than grade 2
  • No other significant, uncontrolled medical or psychiatric condition
  • No serious active infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior specific antitumoral immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • No prior taxanes
  • At least 4 weeks since other prior specific antitumoral chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior specific antitumoral hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior specific antitumoral radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent experimental medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006120


Locations
Show Show 35 study locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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Study Chair: Joseph Gligorov, MD Hopital Tenon

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ClinicalTrials.gov Identifier: NCT00006120    
Other Study ID Numbers: CDR0000068134
FRE-GERCOR-TAXMAX-SOO-1
EU-20029
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: March 2006
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action