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A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer


OBJECTIVES:

- Compare the objective response rate in women treated with paclitaxel with or without
carboplatin as first-line chemotherapy for metastatic breast cancer.

- Compare the overall survival, time to disease progression, and duration of response in
these patients treated with these regimens.

- Compare the safety of these regimens in this patient population.

- Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are
randomized to one of two treatment arms.

- Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.

- Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
weekly for 3 weeks.

Treatment in both arms continues every 4 weeks in the absence of disease progression or
unacceptable toxicity.

Quality of life is assessed at baseline, before each course during study, and then after
completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast cancer

- Must have clinical evidence of stage IV (M1) disease

- HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ
hybridization) OR status unknown

- At least 1 measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Patients with bone-only disease are not eligible

- Ineligible if currently experiencing a complete or partial response to prior hormonal
therapy

- Patients with disease progression after prior response to hormonal therapy are
eligible

- Disease progression without prior hormonal therapy is allowed

- Stable or asymptomatic brain metastasis allowed if:

- Other measurable disease exists

- Cranial irradiation completed and brain metastasis stable for at least 4 weeks
before study

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Pre- or post-menopausal

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2 times ULN

Renal:

- Creatinine no greater than 2 times ULN

- Corrected calcium less than 12 mg/dL

Cardiovascular:

- No New York Heart Association class III or IV heart disease

- No documented myocardial infarction within the past 6 months

- No congestive heart failure

- No unstable angina

- No clinically significant pericardial effusion or arrhythmia

Other:

- No active serious infection

- No prior significant allergic reactions to drugs containing Cremophor, such as
teniposide, cyclosporine, or vitamin K

- No clinically significant (greater than grade 1) peripheral neuropathy

- No other serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell
transplantation

- More than 6 months since prior adjuvant monoclonal antibody therapy

- More than 6 months since prior adjuvant vaccine therapy

- No prior trastuzumab (Herceptin)

- No concurrent anticancer immunotherapy

Chemotherapy:

- No prior chemotherapy for metastatic breast cancer

- More than 6 months since prior adjuvant high-dose chemotherapy

- More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy

- Prior adjuvant taxanes allowed only if administered every 3 weeks

Endocrine therapy:

- See Disease Characteristics

- Any number of prior hormonal therapies for metastatic breast cancer allowed

- Patients with definite signs of progression may begin study therapy immediately
after stopping hormonal therapy

- No concurrent anticancer hormonal agents (including megestrol)

Radiotherapy:

- At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)

- No prior radiotherapy to 30% or more of bone marrow

- No concurrent radiotherapy except for palliation of painful bone metastasis or
pathologic fractures to the area of known lytic disease

Surgery:

- At least 3 weeks since prior major surgery

Other:

- More than 6 months since prior neoadjuvant therapy

- No other concurrent anticancer drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068992

NCT ID:

NCT00025688

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

St. Barnabas Medical CenterLivingston, New Jersey  07039
University of California Davis Cancer CenterSacramento, California  95817
New Britain General HospitalNew Britain, Connecticut  06050
Scott and White ClinicTemple, Texas  76508
Mayo ClinicJacksonville, Florida  32224
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Oncology ConsultantsHouston, Texas  77024
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
Scranton Hematology-OncologyScranton, Pennsylvania  18510
Dean Medical CenterMadison, Wisconsin  53715
Seattle Cancer Care AllianceSeattle, Washington  98109
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Highlands Oncology GroupSpringdale, Arkansas  72764
Texas Cancer CareFort Worth, Texas  76104
Cancer Research Network, Inc.Plantation, Florida  33324
Northern Virginia Oncology Group, P.C.Fairfax, Virginia  22031
West ClinicMemphis, Tennessee  38117
Monterey Bay OncologyMonterey, California  93940
Center for Hematology and OncologyBoca Raton, Florida  33486
MacNeal Cancer CenterBerwyn, Illinois  60402
Oncology Specialists, SCPark Ridge, Illinois  60068
Maryland Hematology/Oncology AssociatesBaltimore, Maryland  21236
Finger Lakes Community Cancer CenterClifton Springs, New York  14432
Clinical Hematology & Oncology Service, Inc.Akron, Ohio  44302
East Tennessee Oncology/Hematology, P.C.Knoxville, Tennessee  37920