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

June 6, 2012 updated by: Eli Lilly and Company

Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Chair: Furhan Yunus, MD, FACP, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 2004

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

April 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017
  • LILLY-B9E-MC-JHQG
  • CDR0000068216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on gemcitabine hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe