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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Furhan Yunus, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Tennessee

Authority:

United States: Federal Government

Study ID:

2017

NCT ID:

NCT00006459

Start Date:

July 2000

Completion Date:

October 2005

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Mountain States Tumor InstituteBoise, Idaho  83712
Southwest Regional Cancer CenterAustin, Texas  78705
Overlook HospitalSummit, New Jersey  07902-0220
Interlakes Oncology/Hematology PCRochester, New York  14623
Arlington Cancer CenterArlington, Texas  76012
University of Tennessee, MemphisMemphis, Tennessee  38163
Pacific Coast Hematology/Oncology Medical GroupFountain Valley, California  92708
Mercy HospitalMiami, Florida  33133
Oklahoma Oncology Inc.Tulsa, Oklahoma  74104
Carle Cancer CenterUrbana, Illinois  61801
HemOnCare, P.C.Brooklyn, New York  11235
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Memorial Medical CenterSpringfield, Illinois  62781
Comprehensive Cancer Care Specialists of Boca RatonBoca Raton, Florida  33428
APN-IMPATH Research CorporationFort Lee, New Jersey  07024
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology GroupMemphis, Tennessee  38119
N.W. Carolina Oncology & Hematology, P.A.Hickory, North Carolina  28603
Intermountain Hematology/Oncology Associates, Inc.Salt Lake City, Utah  84124
North Mississippi Hematology and Oncology Associates, Ltd.Tupelo, Mississippi  38801
Little Rock Hematology-Oncology AssociatesLittle Rock, Arkansas  72205
Office of Alex J.P. MakalinaoLos Angeles, California  90045
Hematology/Oncology GroupSanta Rosa, California  95403
Danbury Internal MedicineDanbury, Connecticut  06810
Indiana Community Cancer Care, Inc.Indianapolis, Indiana  46202
Cancer Health AssociatesMichigan City, Indiana  46360
Rittenhouse Hematology/OncologyPhiladelphia, Pennsylvania  19146
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Office Of C. Michael JonesGermantown, Tennessee  38138
Northern Virginia Oncology Group, P.C.Fairfax, Virginia  22031