Management of Metastatic Breast Cancer in Frail Patients

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Primary Purpose

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Gemcitabine hydrochloride

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Metastatic breast cancer Measurable disease No progression after 3 or more different forms of chemotherapy Hormone receptor positive breast cancer must be refractory to at least two forms of hormonal treatment (including antiestrogen, aromatase inhibitor, and/or progestin) unless there is life threatening metastases (e.g., lymphangitic metastases to the lung or liver metastases) Must meet at least one of the following characteristics for frailty: ECOG 2-4 Dependence in at least one activity of daily living 85 and over History of three or more falls in the past 6 months Mild dementia (must be oriented in time, space, and location) Three or more comorbid conditions Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 65 and over Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Neutropenia or thrombocytopenia secondary to myelophthisis from breast cancer allowed Hepatic: Increased bilirubin allowed Renal: Renal insufficiency allowed Cardiovascular: Congestive heart failure allowed Other: No known allergy to gemcitabine PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy to bony areas or CNS metastases Surgery: Not specified Other: Concurrent bisphosphonates allowed No concurrent participation in other investigational studies

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]).

Secondary Outcome Measures

Number of Participants with Adverse Events

Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3.

Full Information

NCT ID

NCT00005614

First Posted

May 2, 2000

Last Updated

September 21, 2012

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005614

Brief Title

Management of Metastatic Breast Cancer in Frail Patients

Official Title

Management of Metastatic Breast Cancer in Frail Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Withdrawn

Why Stopped

no accrual

Study Start Date

August 1999 (undefined)

Primary Completion Date

June 2000 (Actual)

Study Completion Date

June 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine Treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine hydrochloride

Other Intervention Name(s)

Gemzar

Intervention Description

Gemcitabine via IV

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]).

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3.

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Metastatic breast cancer Measurable disease No progression after 3 or more different forms of chemotherapy Hormone receptor positive breast cancer must be refractory to at least two forms of hormonal treatment (including antiestrogen, aromatase inhibitor, and/or progestin) unless there is life threatening metastases (e.g., lymphangitic metastases to the lung or liver metastases) Must meet at least one of the following characteristics for frailty: ECOG 2-4 Dependence in at least one activity of daily living 85 and over History of three or more falls in the past 6 months Mild dementia (must be oriented in time, space, and location) Three or more comorbid conditions Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 65 and over Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Neutropenia or thrombocytopenia secondary to myelophthisis from breast cancer allowed Hepatic: Increased bilirubin allowed Renal: Renal insufficiency allowed Cardiovascular: Congestive heart failure allowed Other: No known allergy to gemcitabine PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy to bony areas or CNS metastases Surgery: Not specified Other: Concurrent bisphosphonates allowed No concurrent participation in other investigational studies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lodovico Balducci, M.D.

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial