Management of Metastatic Breast Cancer in Frail Patients

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine hydrochloride

• Registration Number: NCT00005614
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

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

Detailed Description

OBJECTIVES: I. Determine the safety and efficacy of gemcitabine in the treatment of elderly women with metastatic breast cancer. II. Evaluate the quality of life in these patients.

OUTLINE: Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2000-05-02
• Primary Completion: 2000-06
• Study Completion: 2000-06
• Study First Submitted QC: 2004-07-23
• Study First Posted: 2004-07-26
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine Treatment	Gemcitabine hydrochloride	Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8 week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2 years, then every 6 months until year 5, and then annually thereafter.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 years	Investigators planned to determine efficacy (objective response rate \[ORR\] by Response Evaluation Criteria In Solid Tumors \[RECIST\]).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	2 years	Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3.