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WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer

2014-08-27 03:12:54 | BioPortfolio

Summary

This is an open-label, pilot study in patients with a diagnosis of primary ovarian, fallopian tube or primary peritoneal carcinoma who have undergone standard cytoreductive surgery following by adjuvant chemotherapy. It is expected that this first surgery was optimal - as defined as no residual tumor > or = 1 centimeter. Patient has clinical evidence of a first recurrence. The patient undergoes surgery and isotonic normal saline (perfusate) is heated and administered into the abdomen, followed by hyperthermic intraperitoneal chemotherapy infusion (HIPC) administering carboplatin (chemotherapy). Six weeks after surgery patients will receive adjuvant chemotherapy with Paclitaxel and Carboplatin for up to 6 cycles.

Description

OBJECTIVES

- The primary objectives are

- to determine the clinical response of hyperthermic intraperitoneal chemotherapy (HIPC) in patients at the time of first clinical recurrence of ovarian, fallopian tube, or primary peritoneal carcinoma

- to determine the feasibility of delivering HIPC in a recurrent setting.

- Secondary objectives are

- to determine disease free survival (DFS) and overall survival (OS),

- to determine treatment related changes in quality of life (QOL)

- to monitor the toxicities and complications associated with HIPC.

Study Design

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

Conditions

Ovarian Cancer

Intervention

Hyperthermic intraperitoneal chemotherapy with Carboplatin, Isotonic saline (perfusate), Surgery, Carboplatin, Paclitaxel

Location

Masonic Cancer Center, University of Minnesota
Minneapolis
Minnesota
United States
55455

Status

Not yet recruiting

Source

Masonic Cancer Center, University of Minnesota

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:54-0400

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Medical and Biotech [MESH] Definitions

Drug treatment designed to further diminish the disease toward complete remission following INDUCTION CHEMOTHERAPY. It helps to consolidate the gains during induction chemotherapy and may be followed by MAINTENANCE CHEMOTHERAPY.

Treatment designed to help prevent a relapse of a disease following the successful primary treatments (INDUCTION CHEMOTHERAPY and CONSOLIDATION CHEMOTHERAPY) with a long-term low-dose drug therapy.

Initial drug treatment designed to bring about REMISSION INDUCTION. It is typically a short-term and high-dose drug treatment that is followed by CONSOLIDATION CHEMOTHERAPY and then MAINTENANCE CHEMOTHERAPY.

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.

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