Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2
18 Years
N/A
Female
Breast Cancer
Trial Information
Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2
OBJECTIVES:
- Compare the response rate associated with two different treatment schedules of
paclitaxel, carboplatin, and trastuzumab (Herceptin) in women with overexpressed HER-2
growth factor receptor and metastatic breast cancer. (Schedule A closed to accrual
effective 05/16/2003).
- Compare the time to progression and median survival in patients treated with these
schedules.
- Compare the toxicity of these treatment schedules in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior adjuvant
therapy (none vs less than 6 months vs at least 6 months), estrogen receptor (ER) status and
progesterone receptor (PR) status at initial diagnosis (ER positive/PR positive or unknown
vs ER positive/PR negative vs ER positive or unknown/PR negative), menopausal status (pre vs
post), and performance status (0 or 1 vs 2). Patients are assigned to 1 of 2 treatment
schedules.
- Schedule A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over
30 minutes and then trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1.
Treatment repeats every 3 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30
minutes every 3 weeks until disease progression. (Schedule A closed to accrual
effective 05/16/2003).
- Schedule B: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over
15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after
carboplatin on day 1. Treatment repeats every 4 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Patients then receive
trastuzumab IV over 30 minutes every 3 weeks until disease progression.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 36-92 patients (18-46 per treatment schedule) will be accrued
for this study within 7-18.5 months. (Schedule A closed to accrual effective 05/16/2003).
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the breast
- Strong overexpression of HER-2 by immunohistochemistry (3+)
- 0-2+ tumors allowed if demonstrate amplification by FISH
- Bidimensionally measurable disease
- Brain metastasis must not represent sole site of disease
- No untreated brain metastasis receiving radiotherapy
- Previously treated brain metastases in continued response to radiotherapy and/or
surgery for at least 2 months allowed
- Hormone receptor status:
- Positive or negative
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
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 mg/dL
- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver
metastases present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No myocardial infarction within the past 6 months
- No congestive heart failure or 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 uncontrolled infection
- No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- Prior adjuvant chemotherapy allowed
- Prior taxane therapy allowed
- No prior cisplatin or carboplatin
- No prior chemotherapy for metastatic disease
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of marrow
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
Other:
- At least 7 days since prior parenteral antibiotics
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Edith A. Perez, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000066689
NCT ID:
NCT00003612
Start Date:
April 1999
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Mayo Clinic | Jacksonville, Florida 32224 |
| Medcenter One Health System | Bismarck, North Dakota 58501 |
| CentraCare Health Plaza | Saint Cloud, Minnesota 56303 |
| Carle Cancer Center | Urbana, Illinois 61801 |
| Altru Cancer Center | Grand Forks, North Dakota 58206 |
