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Spots Global Cancer Trial Database for LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

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Trial Identification

Brief Title: LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

Official Title: A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer

Study ID: NCT00006007

Conditions

Breast Cancer

Study Description

Brief 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. PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.

Detailed Description: OBJECTIVES: * Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy regimen for metastatic disease (unless these were a taxane and anthracycline). * Determine the toxicity of this regimen in this patient population. * Determine time to progression and overall survival of these patients receiving this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8. pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8. Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving a complete response receive 2 additional courses. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States

Mayo Clinic, Jacksonville, Florida, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

Illinois Oncology Research Association, Peoria, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

CCOP - Wichita, Wichita, Kansas, United States

CCOP - Ochsner, New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States

CCOP - Duluth, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CentraCare Health Plaza, Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Medcenter One Health System, Bismarck, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Altru Health Systems, Grand Forks, North Dakota, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States

CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Contact Details

Name: Alex A. Adjei, MD, PhD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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