Clinical trial NCT00006459: Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
Official title: Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2004-02-12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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. Combining more than one drug may kill more tumor cells. It is not yet known if paclitaxel is more effective with or without gemcitabine for advanced breast cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel with or without gemcitabine in treating women who have advanced breast cancer.

Detailed description: OBJECTIVES: I. Compare overall survival of patients with unresectable, locally recurrent, or metastatic breast cancer treated with paclitaxel with or without gemcitabine.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Patients receive paclitaxel with or without gemcitabine. Treatment continues every 21 days in the absence of disease progression. Patients are followed every 2-4 months for 2 years after active treatment.

PROJECTED ACCRUAL: Not specified

National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record when the trial completed. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion date. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically or cytologically proven unresectable, locally recurrent, or metastatic breast cancer not amenable to surgery or radiotherapy of curative intent No inflammatory breast cancer unless evidence of metastatic disease No bone metastases, pleural effusion, or ascites as the only site of disease Clinically measurable disease outside previously irradiated area Relapse after 1 prior adjuvant or neoadjuvant chemotherapy regimen containing anthracycline unless clinically contraindicated No known or suspected brain metastases or recurrence requiring steroids or radiotherapy Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: ALT and AST no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Calcium no greater than 1.2 times ULN Creatinine no greater than 1.5 times ULN Cardiovascular: No active uncontrolled cardiac disease and/or myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other serious systemic disorder precluding study No active infection No severe psychiatric disease No history of hypersensitivity reactions to polyoxyethylated castor oil-based drugs

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation or autologous stem cell infusion following high-dose adjuvant chemotherapy for metastatic disease No concurrent immunotherapy (including humanized anti-HER2 antibody) Chemotherapy: See Disease Characteristics See Biologic therapy No prior chemotherapy for metastatic breast cancer No prior gemcitabine or taxane No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Prior antitumoral hormonal therapy allowed No concurrent hormonal therapy excluding contraceptives and replacement steroids Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: Recovered from prior therapy At least 30 days since prior investigational drugs No concurrent investigational drugs Concurrent bisphosphonate therapy allowed if not begun or stopped within 4 weeks before study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute of Huntsville
state: Alabama
city: Little Rock
country: United States
facility: Little Rock Hematology-Oncology Associates
state: Arkansas
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Office of Alex J.P. Makalinao
state: California
city: Santa Rosa
country: United States
facility: Hematology/Oncology Group
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Danbury
country: United States
facility: Danbury Internal Medicine
state: Connecticut
city: Boca Raton
country: United States
facility: Comprehensive Cancer Care Specialists of Boca Raton
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Community Cancer Care, Inc.
state: Indiana
city: Michigan City
country: United States
facility: Cancer Health Associates
state: Indiana
city: Tupelo
country: United States
facility: North Mississippi Hematology and Oncology Associates, Ltd.
state: Mississippi
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Fort Lee
country: United States
facility: APN-IMPATH Research Corporation
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: HemOnCare, P.C.
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology/Hematology PC
state: New York
city: Hickory
country: United States
facility: N.W. Carolina Oncology & Hematology, P.A.
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Oncology Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: Rittenhouse Hematology/Oncology
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Germantown
country: United States
facility: Office Of C. Michael Jones
state: Tennessee
city: Memphis
country: United States
facility: Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee, Memphis
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Hematology/Oncology Associates, Inc.
state: Utah
city: Fairfax
country: United States
facility: Northern Virginia Oncology Group, P.C.
state: Virginia
Study officials:
affiliation: University of Tennessee
name: Furhan Yunus, MD, FACP
role: STUDY_CHAIR
References:
citation: Smyth EN, Shen W, Bowman L, Peterson P, John W, Melemed A, Liepa AM. Patient-reported pain and other quality of life domains as prognostic factors for survival in a phase III clinical trial of patients with advanced breast cancer. Health Qual Life Outcomes. 2016 Mar 25;14:52. doi: 10.1186/s12955-016-0449-z.