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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00006459
First received: November 6, 2000
Last updated: June 6, 2012
Last verified: April 2002
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Study Start Date: July 2000
Study Completion Date: October 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006459

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States, 35801
United States, Arkansas
Little Rock Hematology-Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States, 92708
Office of Alex J.P. Makalinao
Los Angeles, California, United States, 90045
Hematology/Oncology Group
Santa Rosa, California, United States, 95403
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Connecticut
Danbury Internal Medicine
Danbury, Connecticut, United States, 06810
United States, Florida
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States, 33428
Mercy Hospital
Miami, Florida, United States, 33133
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana Community Cancer Care, Inc.
Indianapolis, Indiana, United States, 46202
Cancer Health Associates
Michigan City, Indiana, United States, 46360
United States, Mississippi
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
United States, New Jersey
APN-IMPATH Research Corporation
Fort Lee, New Jersey, United States, 07024
Overlook Hospital
Summit, New Jersey, United States, 07902-0220
United States, New York
HemOnCare, P.C.
Brooklyn, New York, United States, 11235
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
United States, North Carolina
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, United States, 28603
United States, Oklahoma
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
South Carolina Oncology Associates
Columbia, South Carolina, United States, 29201
United States, Tennessee
Office Of C. Michael Jones
Germantown, Tennessee, United States, 38138
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, United States, 38119
University of Tennessee, Memphis
Memphis, Tennessee, United States, 38163
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
United States, Utah
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Chair: Furhan Yunus, MD, FACP University of Tennessee
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006459     History of Changes
Other Study ID Numbers: 2017, LILLY-B9E-MC-JHQG, CDR0000068216
Study First Received: November 6, 2000
Last Updated: June 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Eli Lilly and Company:
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014