Management of Metastatic Breast Cancer in Frail Patients

This study has been withdrawn prior to enrollment.
(no accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00005614
First received: May 2, 2000
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Metastatic Breast Cancer in Frail Patients

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3.


Enrollment: 0
Study Start Date: August 1999
Study Completion Date: June 2000
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine Treatment
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.
Drug: Gemcitabine hydrochloride
Gemcitabine via IV
Other Name: Gemzar

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005614

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Lodovico Balducci, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00005614     History of Changes
Other Study ID Numbers: MCC-11909, NCI-G00-1748
Study First Received: May 2, 2000
Last Updated: September 21, 2012
Health Authority: United States: Federal Government

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014