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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-G00-1748 | Other Identifier | NCI |
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no accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine hydrochloride | Drug | Gemcitabine via IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Investigators planned to review adverse events utilizing Common Toxicity Criteria (CTC) V3. | 2 years |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Lodovico Balducci, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |