Advertisement

Topics

Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer

2014-08-27 03:15:19 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, 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. Giving ixabepilone together with vorinostat may kill more tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone.

Description

PRIMARY OBJECTIVES:

I. To determine the safety and tolerability of the combination of vorinostat with ixabepilone.

II. To determine the best schedule for delivery of this drug combination. III. To recommend a phase II dose of vorinostat in combination with ixabepilone.

SECONDARY OBJECTIVES:

I. To determine the objective response rate and/or clinical benefit rate. II. To assess the toxicity profile.

TERTIARY OBJECTIVES:

I. Collecting circulating tumor cells pre and post-treatment to study its DNA somatic mutation and methylation assay after the introduction of HDAC inhibitors and ixabepilone.

II. To determine whether administration of vorinostat with ixabepilone will alter the pharmacokinetics of vorinostat.

OUTLINE: This is a phase I, dose-escalation study of vorinostat. Patients are randomized to 1 of 2 treatment arms.

Arm I (Cohort A): Patients receive oral vorinostat once daily on days 1-14 and ixabepilone IV over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm II (Cohort B): Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Male Breast Cancer

Intervention

vorinostat, ixabepilone, laboratory biomarker analysis, pharmacological study

Location

City of Hope
Duarte
California
United States
91010

Status

Recruiting

Source

City of Hope Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:19-0400

Clinical Trials [2928 Associated Clinical Trials listed on BioPortfolio]

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal cells, ...

Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma

This phase I trial is studying the side effects and the best dose of vorinostat when given together with isotretinoin to see how well it works in treating patients with high-risk refractor...

Vorinostat in Treating Patients With Metastatic Melanoma of the Eye

This phase II trial studies how well vorinostat works in treating patients with melanoma of the eye that has spread to other parts of the body. Vorinostat may stop the growth of tumor cell...

Decitabine, Vorinostat, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as cytarabine and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from di...

Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced Solid Tumors

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to ...

PubMed Articles [37156 Associated PubMed Articles listed on BioPortfolio]

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer.

UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel ...

Prostate specific antigen as a biomarker for breast cancer: a meta-analysis study.

To determine whether prostate-specific antigen (PSA) could serve as a biomarker for breast cancer.

Effect of selected drugs on zinc accumulation in teeth of laboratory animals.

Zinc (Zn) is a micronutrient and essential element of life and its deficiency causes severe disorders of numerous body systems, such as immune, reproductive and central nervous system. Zinc supplement...

Cognitive Function and Quality of Life in Vorinostat-Treated Patients Following Matched Unrelated Donor Myeloablative Conditioning Hematopoietic Cell Transplant.

Myeloablative conditioning allogeneic hematopoietic cell transplantation (HCT) puts patients at greater risk for significant cognitive and quality of life decline compared with recipients of reduced i...

Genetic mapping of a male factor subfertility locus on mouse chromosome 4.

Male reproductive anomalies are widely distributed among mammals, and male factors are estimated to contribute to approximately 50% of cases of human infertility. The B10.M/Sgn (B10.M) mouse strain ex...

Medical and Biotech [MESH] Definitions

A scientific or medical discipline concerning the study of male reproductive biology, diseases of the male genital organs, and male infertility. Major areas of interest include ENDOCRINOLOGY; SPERMATOGENESIS; semen analysis; FERTILIZATION; CONTRACEPTION; and CRYOPRESERVATION.

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.

More From BioPortfolio on "Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial