Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide. |
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| Condition | Stages II-III Breast Cancer |
| Intervention | Drug: Nanoparticle Albumin Bound Paclitaxel Drug: doxorubicin Drug: cyclophosphamide |
| Phase | Phase 1 |
| Sponsor | University of Utah |
| Responsible Party | University of Utah |
| ClinicalTrials.gov Identifier | NCT01090128 |
| First Received | March 17, 2010 |
| Last Updated | July 23, 2013 |
| Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 17, 2010 |
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| Last Updated Date | July 23, 2013 |
| Start Date | September 2008 |
| Estimated Primary Completion Date | November 2013 |
| Current Primary Outcome Measures | Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities [Time Frame: one year] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Overall clinical response rate (OcRR) [Time Frame: one year] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer |
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| Official Title | Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer |
| Brief Summary | The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide. |
| Detailed Description | This is a single center, open phase I dose escalation study. This study will assess the highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. Up to 24 patients will be enrolled. The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks. The study will enroll patients with stages II-III, Her-2 negative breast cancer with no prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Stages II-III Breast Cancer |
| Intervention | Drug: Nanoparticle Albumin Bound Paclitaxel IV administered over 30 minutes. The study will test four dose levels. Other Names: AbraxaneDrug: doxorubicin 50 mg/m2 every 3 weeks Other Names: AdriamycinDrug: cyclophosphamide 500 mg/m2 given every 3 weeks |
| Study Arm (s) | Experimental: All patients All participants enrolled. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 24 |
| Estimated Completion Date | November 2013 |
| Estimated Primary Completion Date | November 2013 |
| Eligibility Criteria | Inclusion Criteria: 1. Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 6th Edition, 2002 2. Negative Her-2/neu status 3. ECOG performance status 0 or 1 4. Negative pregnancy test 5. Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram 6. ANC greater than or equal to 1,500/mm3; platelet greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 9 gm/dL 7. Serum bilirubin levels less than or equal to 1.5 mg/dL 8. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to 2.5 X upper limit of normal. 9. Serum creatinine levels less than or equal to 1.5 mg/dL 10. Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. Appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator. 11. Female, greater than or equal to 19 years of age and any race. Exclusion Criteria: 1. Evidence of metastatic disease 2. Concurrent therapy with any other non-protocol anti-cancer therapy 3. Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators 4. Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline 5. History of any other malignancy requiring active treatment 6. Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication 7. Currently active infection. 8. History of HIV infection or chronic hepatitis B or C. 9. The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications 10. Pregnancy or breast feeding 11. A history of a severe hypersensitivity reaction to nab-paclitaxel. 12. Any reason why, in the opinion of the investigator, the patient should not participate. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01090128 |
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| Other Study ID Numbers | HCI53989 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Utah |
| Study Sponsor | University of Utah |
| Collaborators | Celgene Corporation |
| Investigators | Principal Investigator: Hung Khong, MD University of Utah |
| Verification Date | July 2013 |
Locations[ + expand ][ + ]
| University of Utah Huntsman Cancer Institute | Salt Lake City, Utah, United States, 84112 |
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