Clinical Trial: Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer
Brief Summary: This phase I/II trial studies the side effects and best dose of romidepsin when given together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well they work in treating patients with metastatic inflammatory breast cancer. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as 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. Giving romidepsin and paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for inflammatory breast cancer.
Detailed Summary:
PRIMARY OBJECTIVES:
- To assess the safety of the combination of romidepsin plus Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) delivered weekly. (Phase I)
- To determine the maximum tolerated dose (MTD) of romidepsin with full dose weekly Abraxane to define a recommended phase II doses of the combination. (Phase I)
- To assess the progression-free survival (PFS) in patients with human epidermal growth factor receptor 2 (HER2) negative, newly diagnosed metastatic inflammatory breast cancer treated with the combination of romidepsin and Abraxane. (Phase II)
SECONDARY OBJECTIVES:
- To assess the safety and tolerability of the combination of romidepsin and Abraxane.
- To determine the adverse event profile of the combination of romidepsin and Abraxane.
- To assess the overall response rate (ORR) and clinical benefit rate (CBR) in patients with newly recurrent inflammatory breast cancer (IBC) treated with the combination of romidepsin and Abraxane.
OUTLINE: This is a phase I, dose-escalation study of romidepsin followed by a phase II study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes and romidepsin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, an
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Current Primary Outcome:
- Maximum-Tolerated Dose of Romidepsin (Phase I) [ Time Frame: 28 days ]determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0
- Progression-Free Survival (PFS) [ Time Frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of adverse events, graded according to NCI CTCAE version 4.0 [ Time Frame: Up to 30 days ]Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.
- Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]The 95% confidence intervals should be provided.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 5 years ]The 95% confidence intervals should be provided.
Original Secondary Outcome: Same as current
Information By: Thomas Jefferson University
Dates:
Date Received: September 5, 2013
Date Started: April 2014
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017
