Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer

NCT00006459 | Completed Phase 3

• 3 other identifiers: 2017LILLY-B9E-MC-JHQGCDR0000068216
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 31

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer

Interventions

gemcitabine hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (31)

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, 35801, United States

Location

Little Rock Hematology-Oncology Associates

Little Rock, Arkansas, 72205, United States

Location

Pacific Coast Hematology/Oncology Medical Group

Fountain Valley, California, 92708, United States

Location

Office of Alex J.P. Makalinao

Los Angeles, California, 90045, United States

Location

Hematology/Oncology Group

Santa Rosa, California, 95403, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Danbury Internal Medicine

Danbury, Connecticut, 06810, United States

Location

Comprehensive Cancer Care Specialists of Boca Raton

Boca Raton, Florida, 33428, United States

Location

Mercy Hospital

Miami, Florida, 33133, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana Community Cancer Care, Inc.

Indianapolis, Indiana, 46202, United States

Location

Cancer Health Associates

Michigan City, Indiana, 46360, United States

Location

North Mississippi Hematology and Oncology Associates, Ltd.

Tupelo, Mississippi, 38801, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

APN-IMPATH Research Corporation

Fort Lee, New Jersey, 07024, United States

Location

Overlook Hospital

Summit, New Jersey, 07902-0220, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

N.W. Carolina Oncology & Hematology, P.A.

Hickory, North Carolina, 28603, United States

Location

Oklahoma Oncology Inc.

Tulsa, Oklahoma, 74104, United States

Location

Rittenhouse Hematology/Oncology

Philadelphia, Pennsylvania, 19146, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29201, United States

Location

Office Of C. Michael Jones

Germantown, Tennessee, 38138, United States

Location

Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

Memphis, Tennessee, 38119, United States

Location

University of Tennessee, Memphis

Memphis, Tennessee, 38163, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, 84124, United States

Location

Northern Virginia Oncology Group, P.C.

Fairfax, Virginia, 22031, United States

Location

Related Publications (1)

• 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.

  PMID: 27016084 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Furhan Yunus, MD, FACP

  University of Tennessee

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: February 12, 2004
• Study Start: July 1, 2000
• Study Completion: October 1, 2005
• Last Updated: June 7, 2012

Record last verified: 2002-04

Locations

US (31)