LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

• 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.

Study Timeline

• Study First Submitted: 2000-07-05
• Study Start: 2000-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-03
• Study Completion: 2008-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

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

Group	Intervention	Description
gemcitabine + pemetrexed	gemcitabine hydrochloride	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.
gemcitabine + pemetrexed	pemetrexed disodium	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.

Primary Outcome Measures

Name	Time	Method
time to progression	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
overall survival	Up 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

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