Advertisement

Topics

Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors

2014-07-24 14:25:42 | BioPortfolio

Summary

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 paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with advanced or refractory solid tumors.

Description

OBJECTIVES:

Primary

- Determine the recommended phase II dose of vorinostat (SAHA) when administered with paclitaxel and carboplatin in patients with advanced or refractory solid tumors.

Secondary

- Determine the dose-limiting toxicity (DLT) and other toxic effects of this regimen in these patients.

- Assess, preliminarily, evidence of antitumor activity of this regimen in these patients.

- Determine the pharmacokinetic parameters of this regimen in these patients.

- Determine the in vivo effects of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA).

Patients receive oral SAHA once or twice daily on days 1-14* and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease after the completion of 6 courses may receive single-agent SAHA at the discretion of the treating physician.

NOTE: *During the first treatment course only, patients receive SAHA on days -4 to 10.

Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. An additional 6-12 patients are treated at the MTD.

After completion of study treatment, patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention

carboplatin, paclitaxel, vorinostat

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh
Pennsylvania
United States
15232

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:25:42-0400

Clinical Trials [4084 Associated Clinical Trials listed on BioPortfolio]

Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclita...

Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Metastatic Solid Tumors

RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by kil...

Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable Solid Tumors

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

Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, s...

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 [15411 Associated PubMed Articles listed on BioPortfolio]

Light-trigerred Cellular Epigenetic Molecule Release to Reverse Tumor Multi-drug Resistance.

Owing to the high spatial and temporal resolution of light, light related biotechnologies, for example, optogenetics, has wide ranging applications in neuroscience to control a subject's behavior. App...

Complete Response of Metastatic Melanoma to Second Line Chemotherapy with Paclitaxel and Carboplatin - Case Report.

We present a patient with metastatic melanoma who had a complete response to second line chemotherapy with paclitaxel and carboplatin.

A phase II trial of concurrent chemoradiotherapy with weekly paclitaxel and carboplatin in advanced oesophageal carcinoma.

This study was performed to assess the efficacy and feasibility of definitive chemoradiotherapy consisting of weekly doses of combined paclitaxel and carboplatin concurrent with radiation therapy, fol...

Bevacizumab with dose-dense paclitaxel/carboplatin as first-line chemotherapy for advanced ovarian cancer.

Phase III trials have shown improved survival in ovarian cancer patients when the anti-vascular endothelial growth factor (VEGF) therapy bevacizumab is added to first-line chemotherapy. However, furth...

A multi-center randomized controlled study of paclitaxel plus carboplatin versus oral uracil-tegafur as the adjuvant chemotherapy in resected non-small cell lung cancer.

We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC METHODS: In an open-l...

Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

An organoplatinum compound that possesses antineoplastic activity.

A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)

More From BioPortfolio on "Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors"

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...

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 ...


Searches Linking to this Trial