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Home > "O" Clinical Trials Conditions > Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer  Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
For Condition: stage 3A breast cancer,stage 4 breast cancer,stage 3C breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as doxorubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the tumor cells more sensitive to the drugs. PURPOSE: Phase I/II trial to study the effectiveness of combining oblimersen with doxorubicin and docetaxel in treating women who have metastatic or locally advanced breast cancer.
Details: OBJECTIVES: Phase I: - Determine the pharmacokinetics of oblimersen, doxorubicin, and docetaxel in patients with metastatic or locally advanced breast cancer. - Determine the maximum tolerated dose (MTD) of oblimersen in combination with doxorubicin and docetaxel in these patients. - Determine the safety of this regimen in these patients. Phase II: - Determine the therapeutic efficacy of this regimen at the MTD of oblimersen in a neoadjuvant setting, in terms of pathologic complete response rate, in patients with locally advanced breast cancer. - Determine the clinical and imaging response in the breast and axillary lymph nodes of patients treated with this regimen. - Determine the disease-free survival of patients treated with this regimen. - Determine the role of Bcl-2 expression as a predictor of response to this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of oblimersen. - Patients receive oblimersen IV continuously on days 1-5 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 6-12 or pegfilgrastim SC on day 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen 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. - Phase II: Patients receive doxorubicin, docetaxel, G-CSF or pegfilgrastim, and oblimersen at the MTD as in phase I. Patients with resectable tumors after 6 courses undergo surgical resection. Patients are followed every 3-6 months for 5 years. PROJECTED ACCRUAL: A total of 72 patients (12 patients for phase I and 60 patients for phase II) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer meeting 1 of the following staging criteria: - Stage IIIB, IIIC, or IV, including T4, any N, M0; any T, N3, M0; or any T, any N, M1 (phase I) - Stage IIIA, IIIB, or IIIC, including T4, any N, M0; any T, N2-3, M0; or T3, N1, M0 (phase II) - Ipsilateral supraclavicular lymph node metastases allowed - No distant metastases (stage IV) - Measurable disease by physical exam, mammography, or ultrasound (phase II) - No known brain metastases - No symptomatic lymphangitic pulmonary metastases - No leptomeningeal disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 6 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - LVEF at least 45% by MUGA and/or echocardiogram - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No grade 2 or greater neuropathy - No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other agents in this study - No known hypersensitivity to drugs formulated in polysorbate 80 - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude compliance with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered (phase I) - No more than 3 prior chemotherapy regimens for breast cancer (either as adjuvant or neoadjuvant therapy or for metastatic disease) (phase I) - No prior taxane - No prior anthracycline - No prior chemotherapy for breast cancer (phase II) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered (phase I) - No prior radiotherapy for breast cancer (phase II) Surgery - No prior surgery for breast cancer (phase II) Other - No prior oblimersen - No other concurrent anticancer investigational or commercial agents or therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FranciscoEsteva, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Francisco Esteva 713-792-2817
Additional Information:
Study ID Numbers: CDR0000305817; NCI-6023,MDA-DM-02700
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063934
Other Stage 3b Breast Cancer Studies:
1. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Donor Lymphocyte Infusion in Treating Women With Stage IV Breast Cancer
3. Radiation Therapy in Treating Patients With Bone Metastases From Breast or Prostate Cancer
4. Repeated Bone Marrow Transplantation in Treating Patients With Advanced Breast Cancer
5. Anastrozole and Gefitinib Compared With Fulvestrant and Gefitinib in Treating Postmenopausal Women With Recurrent or Metastatic Breast Cancer
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Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer
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