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Breast CancerPhase 3NCT00006459

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

A Phase 3 study testing gemcitabine hydrochloride and paclitaxel in people with Breast Cancer, run by Eli Lilly and Company at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
gemcitabine hydrochloride and paclitaxel
How many people
Not given
Where
31 sitesUnited States
Study dates
Jul 2000to Oct 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites
  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Comprehensive Cancer Care Specialists of Boca Raton

    Boca Raton, Florida, 33428

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • HemOnCare, P.C.

    Brooklyn, New York, 11235

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29201

  • Danbury Internal Medicine

    Danbury, Connecticut, 06810

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Northern Virginia Oncology Group, P.C.

    Fairfax, Virginia, 22031

  • APN-IMPATH Research Corporation

    Fort Lee, New Jersey, 07024

  • Pacific Coast Hematology/Oncology Medical Group

    Fountain Valley, California, 92708

  • Office Of C. Michael Jones

    Germantown, Tennessee, 38138

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

    Hickory, North Carolina, 28603

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Indiana Community Cancer Care, Inc.

    Indianapolis, Indiana, 46202

  • Little Rock Hematology-Oncology Associates

    Little Rock, Arkansas, 72205

  • Office of Alex J.P. Makalinao

    Los Angeles, California, 90045

  • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

    Memphis, Tennessee, 38119

  • University of Tennessee, Memphis

    Memphis, Tennessee, 38163

  • Mercy Hospital

    Miami, Florida, 33133

  • Cancer Health Associates

    Michigan City, Indiana, 46360

  • Rittenhouse Hematology/Oncology

    Philadelphia, Pennsylvania, 19146

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • Intermountain Hematology/Oncology Associates, Inc.

    Salt Lake City, Utah, 84124

  • Hematology/Oncology Group

    Santa Rosa, California, 95403

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Overlook Hospital

    Summit, New Jersey, 07902-0220

  • Oklahoma Oncology Inc.

    Tulsa, Oklahoma, 74104

  • North Mississippi Hematology and Oncology Associates, Ltd.

    Tupelo, Mississippi, 38801

  • Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions
Breast Cancer
Keywords
stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startJul 2000
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006459
Sponsor's protocol ID
2017
Other IDs
LILLY-B9E-MC-JHQG, CDR0000068216
Status last verified
Apr 2002
First submitted
6 Nov 2000
Last updated
7 Jun 2012
Results posted
No

Publications

  • 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.

    PubMed 27016084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine hydrochloride and paclitaxel in people with Breast Cancer, run by Eli Lilly and Company at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006459, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.

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