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Home > "D" Clinical Trials Conditions > Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer  Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
For Condition: stage 3C breast cancer,recurrent breast cancer,stage 4 breast cancer,Male Breast Cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with imatinib mesylate may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel with imatinib mesylate in treating patients who have locally advanced or metastatic breast cancer.
Details: OBJECTIVES: Primary - Determine the safety profile, maximum tolerated dose, and recommended phase II dose of docetaxel when administered with imatinib mesylate in patients with locally advanced or metastatic breast cancer. Secondary - Determine the pharmacokinetic profile of this regimen in these patients. - Determine the potential effects of this regimen on CYP3A4 activity and docetaxel metabolism in these patients. - Correlate docetaxel and imatinib mesylate exposure (utilizing total and unbound docetaxel and imatinib mesylate plasma concentrations) with drug response (e.g., pharmacodynamic effects, drug toxicity, and response) in these patients. - Determine response rate, duration of response, and time to treatment failure in patients treated with this regimen. - Correlate proteomic profile changes in serum with tumor burden and response in patients treated with this regimen. - Correlate pharmacokinetic parameters, tissue expression of specific receptor tyrosine kinases (e.g., c-Kit, platelet-derived growth factor receptor [PDGFR], and phosphorylated PDGFR) in paraffin blocks, and pharmacodynamic assays with antitumor activity of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of docetaxel. Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral imatinib mesylate (STI571) on days 8-28 of course 1 and days 1-28 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity*. Patients with stable or responding disease after at least 2 courses of therapy may discontinue docetaxel and continue therapy with single-agent STI571 until disease progression. NOTE: *Patients experiencing excessive docetaxel-related toxicity who have completed at least 2 full courses may continue on single-agent STI571 in the absence of disease progression or excessive STI571-related toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 6-12 patients receives treatment at the MTD. Patients are followed at 30 days. PROJECTED ACCRUAL: Approximately of 18-30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Stage IIIB, IIIC, or IV disease - Measurable or evaluable disease - Stable brain metastases allowed provided prior surgery or radiotherapy was completed more than 90 days ago - No documented or suspected leptomeningeal disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Male or female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Granulocyte count 1,500/mm^3 - Hemoglobin 8.0 g/dL - Platelet count 100,000/mm^3 Hepatic - Bilirubin upper limit of normal (ULN) - Meets 1 of the following criteria for AST or ALT AND alkaline phosphatase: - AST or ALT ULN AND alkaline phosphatase 5 times ULN - AST or ALT 2.5 times ULN AND alkaline phosphatase ULN - AST or ALT 1.5 times ULN AND alkaline phosphatase 2.5 times ULN - No known acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal - Creatinine 1.5 mg/dL Cardiovascular - No New York Heart Association class III or IV heart disease - No congestive heart failure - No myocardial infarction within the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation - No other primary malignancy except those malignancies that are clinically insignificant AND do not require active intervention - No other concurrent severe and/or life-threatening medical disease - No significant history of noncompliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - At least 2 weeks since prior trastuzumab (Herceptin®) - No concurrent trastuzumab - No concurrent biologic therapy for the primary malignancy Chemotherapy - Prior taxane therapy, including docetaxel, in the adjuvant or metastatic setting allowed - At least 3 weeks since prior chemotherapy (2 weeks for weekly or oral chemotherapy and 6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - At least 2 weeks since prior hormonal therapy - No concurrent antiestrogen therapy - No concurrent routine systemic corticosteroid therapy except as premedication for chemotherapy - Concurrent megestrol allowed only as an appetite stimulant Radiotherapy - See Disease Characteristics - At least 14 days since prior radiotherapy - No prior radiotherapy to only site of measurable/evaluable disease unless there is new evidence of post-radiotherapy disease progression - No concurrent radiotherapy Surgery - See Disease Characteristics - More than 2 weeks since prior major surgery Other - Recovered from all prior therapy - At least 2 weeks since prior daily or weekly investigational treatment - No concurrent warfarin for full anticoagulation - Concurrent low-dose warfarin (e.g., 1 mg/day) allowed for prophylaxis of central venous access - No concurrent treatment with any of the following: - Phenobarbital - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Hypericum perforatum (St. John’s wort) - No other concurrent therapies for the primary malignancy - No other concurrent investigational drugs or systemic therapy - No concurrent bisphosphonates unless started before study therapy - No concurrent grapefruit juice
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntonioWolff, Principal Investigator, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Antonio Wolff 410-614-4192
Additional Information:
Study ID Numbers: CDR0000354504; JHOC-J0214,SKCCC-J0214
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080665
Other Stage 3c Breast Cancer Studies:
1. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
2. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
3. Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
4. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
5. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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