Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer (NCT01938833) | Clinical Trial Compass
TerminatedPhase 1/2
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer
Stopped: Closed by Sponsor
United States9 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed breast carcinoma with a clinical diagnosis of IBC based on the presence of inflammatory changes in the involved breast, such as diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast. Pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis.
✓. Patients may have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0 or non-measurable tumors
✓. Patients must have demonstrated metastatic disease and not received \>2 lines of systemic therapy for metastatic disease
✓. Age \> 18 years
✓. ECOG performance status 0, 1 or 2
✓. Patients must have normal organ and marrow function as defined below: a) Leukocytes \> 2,500/mcL b) Absolute neutrophil count \> 1,500/mcL c) Hemoglobin \> 9 g/dl d) Platelets \> 100,000/mcL e) Total bilirubin \< 1.5 mg/dl f) AST/ALT (SGOT/SGPT) \< 2.5 x ULN g) Alkaline Phosphatase \< 2.5 x ULN (unless bone metastasis is present in the absence of liver metastasis, in which case 3.0 x ULN would be acceptable. h) Serum magnesium \> 1.8 mg/dL i) Serum creatinine \< 1.5 mg/dl j) Serum potassium \> 3.8 mmol/L
✓
What they're measuring
1
Maximum-Tolerated Dose of Romidepsin (Phase I)
Timeframe: 28 days
2
Progression-Free Survival (PFS)
Timeframe: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Trial details
NCT IDNCT01938833
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Tumor negative for HER2 expression (0 or 1+ by IHC) or negative FISH testing
✓. Patients must have a life expectancy of at least 12 weeks
Exclusion criteria
✕. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse event from agents administered more than 4 weeks earlier
✕. Patients may not be receiving any other investigational agents or active anti-neoplastic therapies
✕. Patients who have previously received romidepsin or Abraxane
✕. Patients with untreated or uncontrolled brain metastases or leptomeningeal disease
✕. Patients with known hypersensitivity to any of the components of romidepsin or who have had hypersensitivity reactions to paclitaxel
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements