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SU5416 and Carboplatin to Treat Ovarian Cancer

2014-08-27 03:57:29 | BioPortfolio

Summary

SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to be inversely related to prognosis in ovarian cancer, SU5416 may prove to be a useful agent in this disease. Platinum agents currently provide the most effective treatment for ovarian cancer. However, ovarian cancer often becomes refractory to platinum therapy, leaving the patient with a poor prognosis. This is a phase I study designed to: a) determine a dose level of carboplatin to use in combination with an established dose of SU5416 for treatment of patients with platinum-refractory ovarian cancer, b) assess the side effect profile of SU5416 and carboplatin combination therapy, c) characterize any alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in combination with carboplatin, d) characterize carboplatin pharmacokinetic and pharmacodynamic parameters when given in combination with SU5416, e) do exploratory studies to assess the effect of SU5416 on platinum-DNA adduct levels, f) do exploratory studies to assess any alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416, and g) obtain preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with platinum-refractory ovarian carcinoma.

Description

SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to be inversely related to prognosis in ovarian cancer, SU5416 may prove to be a useful agent in this disease. Platinum agents currently provide the most effective treatment for ovarian cancer. However, ovarian cancer often becomes refractory to platinum therapy, leaving the patient with a poor prognosis. This is a phase I study designed to: a) determine a dose level of carboplatin to use in combination with an established dose of SU5416 for treatment of patients with platinum-refractory ovarian cancer, b) assess the side effect profile of SU5416 and carboplatin combination therapy, c) characterize any alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in combination with carboplatin, d) characterize carboplatin pharmacokinetic and pharmacodynamic parameters when given in combination with SU5416, e) do exploratory studies to assess the effect of SU5416 on platinum-DNA adduct levels, f) do exploratory studies to assess any alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416, and g) obtain preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with platinum-refractory ovarian carcinoma.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

Fallopian Tube Neoplasm

Intervention

SU5416 and carboplatin

Location

National Cancer Institute (NCI)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:29-0400

Clinical Trials [1358 Associated Clinical Trials listed on BioPortfolio]

ABI-007 With Carboplatin as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

The primary purpose of this study is to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with carboplatin (area u...

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Pembrolizumab and Carboplatin in Treating Patients With Relapsed or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

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Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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PubMed Articles [1125 Associated PubMed Articles listed on BioPortfolio]

Papilloma of the Fallopian Tube: A Rare Gynecologic Neoplasm Harboring a BRAF (c.1799T>A) Mutation (V600E).

Papillomas of the fallopian tube are exceedingly rare benign tumors, and only very few cases have been reported in the literature. Clinically, they may present as a mass lesion or occur without sympto...

The effects of hydrocortisone on tight junction genes in an in vitro model of the human fallopian epithelial cells.

The tight junction between epithelial cells helps making connections in the fallopian tube and contributes to successful fertilization. Breaking the tight junction complex induces various diseases suc...

Tuboperitoneal fistula, ectopic pregnancy, and remnants of fallopian tube: a confocal microtomography analysis and 3D reconstruction of human fallopian tube pathologies.

The aim of this study was to provide a three-dimensional (3D) microscopic reconstruction of morphological modifications of the fallopian tube (FT) following surgical sterilization (including tuboperit...

Isolated Fallopian Tube Torsion: A Unique Ultrasound Identity or a Serial Copycat?

To report the preoperative ultrasound (US) signs of isolated fallopian tube torsion in surgically verified cases and to estimate whether preoperative US detection of this condition can be improved.

A Phase 1 Clinical Trial of Guadecitabine and Carboplatin In Platinum-Resistant, Recurrent Ovarian Cancer: Clinical, Pharmacokinetic And Pharmacodynamic Analyses.

Epigenetic changes are implicated in acquired resistance to platinum. Guadecitabine is a next-generation hypomethylating agent (HMA). Here we report the clinical results, along with pharmacokinetic (P...

Medical and Biotech [MESH] Definitions

Diseases involving the FALLOPIAN TUBES including neoplasms (FALLOPIAN TUBE NEOPLASMS); SALPINGITIS; tubo-ovarian abscess; and blockage.

Methods for assessing the patency of the fallopian tubes.

Benign or malignant neoplasms of the FALLOPIAN TUBES. They are uncommon. If they develop, they may be located in the wall or within the lumen as a growth attached to the wall by a stalk.

Formation of an artificial opening in a fallopian tube.

A pair of highly specialized muscular canals extending from the UTERUS to its corresponding OVARY. They provide the means for OVUM collection, and the site for the final maturation of gametes and FERTILIZATION. The fallopian tube consists of an interstitium, an isthmus, an ampulla, an infundibulum, and fimbriae. Its wall consists of three histologic layers: serous, muscular, and an internal mucosal layer lined with both ciliated and secretory cells.

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