Advertisement

Topics

Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

2014-08-27 03:13:34 | BioPortfolio

Summary

The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is safety and tolerable when administered to patients with locally advanced or metastatic bladder cancer and to gain preliminary data on whether patients may benefit from this combination. experience benefit.

Description

This open-label, multicenter, randomized study will consist of 2 phases:

- Phase Ib: a safety run-in period with 3 ascending doses of eribulin;

- Phase II: a randomized 2-arm design. Phase Ib Patients will be recruited into cohorts, with a minimum of 3 and a maximum of 6 patients per cohort. All patients will receive the same dose of gemcitabine (1000 mg/m2 on Days 1 and 8 of a 21-day cycle) and cisplatin (70 mg/m2 on Day 1) in combination with eribulin (administered on Days 1 and 8 of the cycle). All patients in a cohort will receive the same dose level of eribulin.

The dose level of eribulin will be escalated for additional cohorts unless greater than 2 dose limiting toxicities (DLTs) are reported at the lower dose level(s) prior to enrollment of the next dose level. If one DLT occurs at any dose level, the cohort will be expanded to include up to a maximum of 6 patients.

A Dose Escalation Committee will determine when no further dose escalation is appropriate and whether the MTD will be defined as a preceding dose or an intermediate dose.

Phase II Patients will be randomized in a 1:1 ratio to receive either eribulin in combination with gemcitabine plus cisplatin or gemcitabine plus cisplatin alone. The eribulin dose will be determined in the Phase Ib portion of the study.

One cycle of therapy will last 21 days, with a maximum number of 6 cycles. Radiologic examinations including a computed tomography (CT) scan of the chest, abdomen, and pelvis as appropriate (and CT or magnetic resonance imaging [MRI] scan as appropriate), will be performed during Screening and after every 2 cycles until disease progression. Radiographic assessments should be repeated at withdrawal if the last assessment was obtained greater than 3 weeks from withdrawal of therapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

gemcitabine plus cisplatin, E7389 in combination with gemcitabine plus ciplatin

Location

Arizona Clinical Research Center, Inc.
Tucson
Arizona
United States
85715

Status

Recruiting

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:34-0400

Clinical Trials [2117 Associated Clinical Trials listed on BioPortfolio]

Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients tak...

A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

The purposes of this study are to determine: 1. If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone. ...

Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients

To determine the efficacy in terms of objective response rate (ORR) of the combination of durvalumab and tremelimumab in addition with gemcitabine or in addition with gemcitabine and cispl...

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with g...

Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic ...

PubMed Articles [879 Associated PubMed Articles listed on BioPortfolio]

Gemcitabine and cisplatin for treatment of lung cancer in vitro and vivo.

To evaluate the antitumor activity of gemcitabine (GEM), cisplatin (DDP) as well as the combination of these two agents in lung cancer cells and mice.

Inhibition of MAPKAPK2/MK2 facilitates DNA replication upon cancer cell treatment with gemcitabine but not cisplatin.

The signaling pathway driven by p38 and MAPKAPK2 alias MK2 is activated as part of stress responses, and these kinases represent attractive drug targets for cancer therapy. However, seemingly conflict...

Biomarker assessment of the CBCSG006 trial: A randomized phase III trial of cisplatin plus gemcitabine compared with paclitaxel plus gemcitabine as first-line therapy for patients with metastatic triple-negative breast cancer.

CBCSG006 trial reported the superior efficacy of cisplatin plus gemcitabine (GP) regimen than paclitaxel plus gemcitabine (GT) regimen as first-line treatment of metastatic triple-negative breast canc...

USP9X inhibition improves gemcitabine sensitivity in pancreatic cancer by inhibiting autophagy.

Gemcitabine is the cornerstone of pancreatic cancer treatment. Although effective in most patients, development of tumor resistance to gemcitabine can critically limit its efficacy. The mechanisms res...

Neoadjuvant chemotherapy with gemcitabine and cisplatin for muscle-invasive bladder cancer: multicenter retrospective study.

The aim of this study was to evaluate the efficacy of neoadjuvant gemcitabine and cisplatin (GC) therapy for muscle-invasive bladder cancer (MIBC).

Medical and Biotech [MESH] Definitions

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.

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Organic cation transporter consisting of twelve transmembrane domains and expressed primarily in the kidney. It transports a wide range of metabolites, drugs, and neurotransmitters from the blood to the KIDNEY TUBULES, including DOPAMINE; SEROTONIN; CHOLINE; and CISPLATIN.

Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.

Therapy with two or more separate preparations given for a combined effect.

More From BioPortfolio on "Eribulin Mesylate Administered in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Urology
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

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