Advertisement

Topics

ABT-888, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

2014-08-27 03:14:34 | BioPortfolio

Summary

RATIONALE: ABT-888 may stop the growth of some tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. Giving ABT-888 together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with cisplatin and vinorelbine ditartrate in treating patients with recurrent and/or metastatic breast cancer.

Description

PRIMARY OBJECTIVES:

I. The primary objective of the study is to determine the MTD of ABT-888 when administered daily for 14 days out of a 21 day cycle in combination with cisplatin and vinorelbine in subjects with metastatic TNBC and BRCA mutation associated breast cancer.

SECONDARY OBJECTIVES:

I. Assess the pharmacokinetic profile of ABT-888 when combined with cisplatin and vinorelbine and the safety/tolerability profile of the combination.

II. Evaluate the level of PARP inhibition at each dose level to determine whether maximal PARP inhibition is achieved.

III. Identify the subgroup of triple negative breast cancer patients who will potentially derive the most benefits from PARP inhibition combined with platinum-based chemotherapy.

OUTLINE:

This is a dose-escalation study of ABT-888.

Patients receive oral ABT-888 twice daily on days 1-14 (days 0-13 of course 1 only). Patients also receive cisplatin IV over 1 hour on day 1 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Treatment repeats every 21 days for 6- 10 courses in the absence of disease progression or unacceptable toxicity. Treatment with ABT-888 alone may continue in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 30 days.

Study Design

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

Conditions

Estrogen Receptor-negative Breast Cancer

Intervention

immunohistochemistry staining method, gene expression analysis, ABT-888, cisplatin, vinorelbine ditartrate, pharmacological study, laboratory biomarker analysis

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
19024-1024

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:34-0400

Clinical Trials [2859 Associated Clinical Trials listed on BioPortfolio]

Lapatinib and Vinorelbine in Treating Patients With Advanced Solid Tumors

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

Studying Gene Expression and Location in Samples From Patients With Brain Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to brain tumors. PURPOSE: This re...

Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cance...

Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimu...

Biomarkers in Tissue Samples From Patients With Breast Cancer Treated With Bevacizumab

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in tissue samples from pa...

PubMed Articles [37091 Associated PubMed Articles listed on BioPortfolio]

Effect of cisplatin on the clock genes expression in the liver, heart and kidney.

Cisplatin is a platinum-based chemotherapy drug is widely used to treat various types of malignancies. Although the involvement of circadian clock in cisplatin metabolism and excretion has been report...

Adjuvant vinorelbine and cisplatin after complete resection of stage II and III non-small cell lung cancer: long-term follow-up of our study of Japanese patients.

We reported previously a phase II study of adjuvant chemotherapy consisting of four cycles of vinorelbine (25 mg/m) and cisplatin (40 mg/m), given on days 1 and 8, every 4 weeks, to Japanese patien...

Collagen IV and laminin-1 expression in embryonic mouse lens using principal components analysis technique.

Immunohistochemistry section staining is not always easy to interpret. Manual quantification of immunohistochemical staining is limited by the observer visual ability to detect changes in level staini...

Tracing Gene Expression Through Detection of β-galactosidase Activity in Whole Mouse Embryos.

The Escherichia coli LacZ gene, encoding β-galactosidase, is largely used as a reporter for gene expression and as a tracer in cell lineage studies. The classical histochemical reaction is based on t...

p-STAT3 in luminal breast cancer: Integrated RNA-protein pooled analysis and results from the BIG 2-98 phase III trial.

In the present study, in order to investigate the role of signal transducer and activator of transcription 3 (STAT3) in estrogen receptor (ER)-positive breast cancer prognosis, we evaluated the phos...

Medical and Biotech [MESH] Definitions

MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.

The expression of a gene in an abnormal place, or at an abnormal time in an organism. Ectopic Gene Expression is often induced artificially by genetic techniques.

A form of gene interaction whereby the expression of one gene interferes with or masks the expression of a different gene or genes. Genes whose expression interferes with or masks the effects of other genes are said to be epistatic to the effected genes. Genes whose expression is affected (blocked or masked) are hypostatic to the interfering genes.

A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

More From BioPortfolio on "ABT-888, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

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...


Searches Linking to this Trial