Status:
WITHDRAWN
Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
CTI BioPharma
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and capecitabine. It is exp...
Eligibility Criteria
Inclusion
- SWOG performance status of 0-2
- Projected life expectancy of at least 3 months
- Female age 18 years and over
- Provision of informed consent prior to any study-related procedures.
- Hormone receptor positive or negative tumor
- Her 2 neu negative tumor
- Negative pregnancy test for women of childbearing potential
- Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- ANC \> 1500, Platelet count \> 100,000, Hemoglobin \> 9.0
- Serum creatinine \< 1.5 mg/dl
- Hepatic function: Patients must have adequate liver functions: AST or ALT \< 2.5 X upper limit of normal (ULN), alkaline phosphatase \< 2.5 X upper limit of normal. Serum Bilirubin \< 1.5 mg
- Peripheral neuropathy grade 0-1
- No other concomitant therapy directed at the cancer is allowed.
Exclusion
- Serum bilirubin \> 1.5 the upper limit of reference range (ULRR)
- Serum creatinine \>1.5
- Prior therapy for this tumor.
- Clinical Congestive Heart Failure
- Women who are currently pregnant or breast feeding.
- Receipt of any investigational agents within 30 days prior to commencing study treatment
- Prior radiation must not have included ≥ 30% of major bone marrow containing areas (pelvis, lumbar spine)
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma in-situ of the breast (LCIS), or any other cancer from which the patient has been disease-free for 5 years. Patients with prior invasive breast cancer or ductal carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years and did not receive prior treatment with doxorubicin and/or a taxane.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01227408
Start Date
February 1 2009
End Date
February 1 2011
Last Update
May 2 2017
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033