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Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Phase II Trial of Docetaxel and Carboplatin as First-Line Therapy for Metastatic Breast Cancer


OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with
metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to
progression, and survival in patients treated with this regimen. III. Determine the toxic
effects of this regimen in these patients. IV. Assess the common functional polymorphisms in
genes involved in chemotherapeutic response to improve prediction of clinical outcomes and
provide insight into the potential for genotype-specific drug dosage.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and
carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of
disease progression or unacceptable toxicity. Patients who achieve stable disease (SD),
partial response (PR), or complete response (CR) may receive 4 additional courses past SD,
PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A maximum of 55 patients will be accrued for this study within 11 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the breast
Measurable disease At least 20 mm in at least 1 dimension Hormone receptor status: Not
specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline
phosphatase no greater than ULN OR SGOT/SGPT no greater than ULN Alkaline phosphatase no
greater than 4 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular:
No myocardial infarction within the past 6 months No congestive heart failure No unstable
angina No clinically significant pericardial effusion or arrhythmia Other: No other
invasive malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix No active unresolved
infection No prior hypersensitivity reaction to docetaxel No grade 2 or greater sensory or
motor neuropathy Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
during the first course of study therapy Chemotherapy: No prior chemotherapy for
metastatic disease Prior adjuvant chemotherapy allowed More than 1 year since prior
paclitaxel, docetaxel, cisplatin, or carboplatin No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy
to breast, chest wall, or axilla No prior radiotherapy to greater than 30% of bone marrow
No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and
recovered Other: More than 7 days since prior IV antibiotics No concurrent experimental
drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Edith A. Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067945

NCT ID:

NCT00005963

Start Date:

November 2000

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501