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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Women With Metastatic Breast Cancer  Chemotherapy in Treating Women With Metastatic Breast Cancer
Chemotherapy in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Completed
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: 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 DX-8951f in treating women who have metastatic breast cancer that has not responded to previous therapy.
Details: OBJECTIVES: I. Determine the antitumor activity of DX-8951f in women with metastatic adenocarcinoma of the breast who have failed prior therapy with an anthracycline and a taxane. II. Evaluate the quantitative and qualitative toxicities of this drug in these patients. III. Evaluate the pharmacokinetics of this drug in these patients. PROTOCOL OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic adenocarcinoma of the breast - Prior treatment with an anthracycline (e.g., doxorubicin or epirubicin) and a taxane (e.g., paclitaxel or docetaxel) either as adjuvant therapy or for advanced disease - Bidimensionally measurable disease; Sentinel lesions must be outside of any prior radiation port - No resected disease or stage IV with no evaluable disease - No brain metastases or leptomeningeal disease - No symptomatic lymphangitic pulmonary metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy; No prophylactic colony stimulating factors to prevent neutropenia (except when neutropenia fever occurs despite dose reduction) - Chemotherapy: See Disease Characteristics; No greater than 3 prior chemotherapy regimens for metastatic breast cancer or as either adjuvant or neoadjuvant therapy; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered; No other concurrent cytotoxic chemotherapy - Endocrine therapy: Exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed; At least 3 weeks since prior hormonal therapy except for: Patients who are highly unlikely to have a withdrawal response to cessation of hormonal therapy (e.g., patients with disease that is primarily resistant to hormonal therapy, patients without prior partial response, or stabilization of disease lasting less than 6 months); Patients with new or extensive visceral metastases; Patients with rapidly progressive or symptomatic metastases during hormonal therapy - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy and recovered; No prior radiotherapy to greater than 50% of bone marrow; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery and recovered; No concurrent surgery - Other: No other concurrent anticancer treatment; At least 28 days since other prior investigational drugs, including analgesics or antiemetics; No other investigational drugs during and for 28 days after the study; No drugs that induce or inhibit CYP3A enzyme --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Hemoglobin at least 9.0 g/dL; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No active congestive heart failure; No uncontrolled angina; No myocardial infarction within past 6 months - Neurologic: No history of an existing grade 3-4 peripheral neuropathy of any etiology - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No allergy to camptothecin or its derivatives; No concurrent serious infection; No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix; No overt psychosis, mental disability, or incompetence; No other life threatening disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067148; DAIICHI-8951A-PRT011,MDA-ID-98308
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004046
Other Recurrent Breast Cancer Studies:
1. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
2. Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
3. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
4. Vaccine Therapy in Treating Women With Metastatic Breast Cancer
5. Biological Therapy in Treating Women With Stage IV Breast Cancer
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Chemotherapy in Treating Women With Metastatic Breast Cancer
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