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PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER


OBJECTIVES:

- Compare the response rate in women with metastatic or locally advanced, inoperable
adenocarcinoma of the breast treated with docetaxel vs paclitaxel.

- Compare the toxicity of these regimens in these patients.

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

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 3 weeks
in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Courses repeat every 3
weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after courses 4 and 6.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of
the breast

- Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or
CT or abdominal CT do not require histologic confirmation)

- Hot spots on bone scan not shown to be malignant on plain x-rays are not
adequate evidence of malignant disease in the absence of other lesions

- Must meet 1 of the following conditions:

- Disease progression after 1 prior chemotherapy regimen for locally advanced or
metastatic disease (which may or may not have followed a separate adjuvant
regimen using chemotherapy or hormonal therapy)

- Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant
chemotherapy regimen

- One of the above chemotherapy regimens must have contained an anthracycline
(e.g., doxorubicin, but not mitoxantrone)

- Single drug substitution (e.g., methotrexate for doxorubicin) during prior
combination chemotherapy allowed

- Bidimensionally measurable

- No clinical or radiographic evidence of brain or leptomeningeal disease

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Karnofsky 60-100% OR

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count at least 2,000/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin normal

- SGOT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

- No uncontrolled hypercalcemia

Cardiovascular:

- No myocardial infarction within the past 6 months

- No history of arrhythmia requiring treatment

- No heart block

- No clinical evidence of congestive heart failure

- No unstable angina (e.g., new onset, crescendo, or rest angina)

- Stable exertional angina allowed

Other:

- No current symptomatic grade 2 or greater peripheral neuropathy

- No history of hypersensitivity to products containing Cremophor EL (e.g.,
cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide)

- No serious infection

- No significant psychiatric disease that would preclude study

- No other malignancy within the past 5 years except nonmelanomatous skin cancer or
completely excised carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow or stem cell transplantation

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6
weeks for nitrosoureas or mitomycin)

- No prior high-dose chemotherapy given with ablative intent

- No prior taxoids

- No other concurrent antineoplastic therapy

Endocrine therapy:

- See Disease Characteristics

- Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed

- At least 1 week since prior hormonal therapy

- No concurrent corticosteroids except:

- Prophylaxis or treatment for acute hypersensitivity reactions

- Chronic therapy (more than 6 months) at low doses (20 mg/day or less of
methylprednisolone or equivalent)

Radiotherapy:

- At least 4 weeks since prior radiotherapy to major bone marrow areas

- No prior high-dose radiotherapy given with ablative intent

- No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a
solitary rib fracture) during objective response

Surgery:

- See Disease Characteristics

- More than 2 weeks since prior surgery except simple biopsy or placement of venous
access device

Other:

- At least 4 weeks since prior investigational drugs

- Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta
blockers, or calcium channel blockers) allowed

- No concurrent ketoconazole

- No concurrent bisphosphonates unless initiated more than 3 months before
randomization

- No concurrent experimental drug or therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Peter M. Ravdin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Federal Government

Study ID:

CDR0000064232

NCT ID:

NCT00002662

Start Date:

August 1994

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

George Washington University Medical CenterWashington, District of Columbia  20037
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Baptist Regional Cancer Center - KnoxvilleKnoxville, Tennessee  37901
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Baptist Regional Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Montclair Regional Cancer CenterBirmingham, Alabama  35213
Highlands Oncology Group, P.A. - FayettevilleFayetteville, Arkansas  72703
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
California Cancer Care, Inc.Greenbrae, California  94904-2007
Green Cancer Center at Scripps ClinicLa Jolla, California  92037
Sidney Kimmel Cancer CenterSan Diego, California  92121
Norwich Cancer CenterNorwich, Connecticut  06360
Georgia Cancer Specialists - DeKalbDecatur, Georgia  30033
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Tufts - New England Medical CenterBoston, Massachusetts  02111
Southfield Oncology Institute, Inc.Southfield, Michigan  48076-3779
Mercy Arch Hematology Oncology, P.C.Saint Louis, Missouri  63141
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Hematology Oncology Consultants IncColumbus, Ohio  43235
Oncology-Hematology AssociatesPhiladelphia, Pennsylvania  19107
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Greenville Hospital SystemGreenville, South Carolina  29605
Charles A. Sammons Cancer CenterDallas, Texas  75246