Breast Cancer Clinical Trial
Official title:
Management of Metastatic Breast Cancer in Frail Patients
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2000 |
Est. primary completion date | June 2000 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 65 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) | Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]). | 2 years | No |
Secondary | Number of Participants with Adverse Events | Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3. | 2 years | Yes |
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