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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00616967 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: vorinostat Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Official Title: | A Multi-Institutional Double-Blind Phase II Study Evaluating Response and Surrogate Biomarkers to Carboplatin and Nab-Paclitaxel (CP) With or Without Vorinostat as Preoperative Chemotherapy in HER2-Negative Primary Operable Breast Cancer |
Estimated Enrollment: | 74 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other: placebo
Given orally
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Arm II: Experimental
Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Drug: vorinostat
Given orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed infiltrating ductal breast cancer by core needle biopsy
Unresected, clinically measurable disease, meeting 1 of the following clinical staging criteria:
Hormone receptor status* meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior chemotherapy, radiotherapy, or endocrine therapy for this cancer
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Study Chair: | Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Vered Stearns ) |
Study ID Numbers: | CDR0000586335, JHOC-SKCCC-J0785 |
Study First Received: | February 14, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00616967 History of Changes |
Health Authority: | Unspecified |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer ductal breast carcinoma lobular breast carcinoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Skin Diseases Vorinostat Breast Neoplasms Carboplatin Antimitotic Agents Carcinoma Carcinoma, Lobular Analgesics, Non-Narcotic |
Paclitaxel Tubulin Modulators Carcinoma, Ductal, Breast Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Antineoplastic Agents, Phytogenic Breast Diseases |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Breast Diseases Skin Diseases Vorinostat Mitosis Modulators |
Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Carboplatin Protective Agents Pharmacologic Actions Neoplasms Paclitaxel Analgesics, Non-Narcotic Tubulin Modulators Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |