Clinical trial NCT00025688: Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-08-05
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Monterey
country: United States
facility: Monterey Bay Oncology
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: New Britain
country: United States
facility: New Britain General Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: Center for Hematology and Oncology
state: Florida
city: Hollywood
country: United States
facility: Cancer Research Network, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Berwyn
country: United States
facility: MacNeal Cancer Center
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders
state: Maine
city: Baltimore
country: United States
facility: Maryland Hematology/Oncology Associates
state: Maryland
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: Clifton Springs
country: United States
facility: Finger Lakes Community Cancer Center
state: New York
city: Akron
country: United States
facility: Clinical Hematology & Oncology Service, Inc.
state: Ohio
city: Scranton
country: United States
facility: Scranton Hematology-Oncology
state: Pennsylvania
city: Knoxville
country: United States
facility: East Tennessee Oncology/Hematology, P.C.
state: Tennessee
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Cancer Care
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Temple
country: United States
facility: Scott and White Clinic
state: Texas
city: Fairfax
country: United States
facility: Northern Virginia Oncology Group, P.C.
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Madison
country: United States
facility: Dean Medical Center
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Edith A. Perez, MD
role: STUDY_CHAIR
References: