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LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Registration Number
NCT00006007
Lead Sponsor
Alliance for Clinical Trials in Oncology
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
59
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
gemcitabine + pemetrexedgemcitabine hydrochloridePatients 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.
gemcitabine + pemetrexedpemetrexed disodiumPatients 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.
Primary Outcome Measures
NameTimeMethod
time to progressionUp to 5 years
Secondary Outcome Measures
NameTimeMethod
overall survivalUp to 5 years

Trial Locations

Locations (24)

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

Scroll for more (14 remaining)
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States

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