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.
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
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
- Being tested
- gemcitabine hydrochloride, paclitaxel
- 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.
- First posted12 Feb 2004 (estimated)
- Study startJul 2000
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Furhan Yunus, MD, FACP, Study chair, University of Tennessee
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00006459
- Acronym / sponsor ID
- 2017
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 27016084Smyth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furhan Yunus, MD, FACP study chair
University of Tennessee
31 sites in 1 country: see every site and its status.
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.