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Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma

2014-07-24 14:16:02 | BioPortfolio

Summary

Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.

Description

Primary Objectives:

- Phase I: to determine the maximum tolerated dose (MTD) of oxaliplatin in combination with gemcitabine and capecitabine (GEMOXEL) in patients with APC

- Phase II: to assess any anti-tumor activity of GEMOXEL in patients with APC

Secondary Objectives:

- to assess toxicity and safety of the combination treatment GEMOXEL in patients with APC

Primary Endpoints:

- Phase I: Dose-limiting toxicity

- Phase II: Objective tumor response

Secondary Endpoints:

- Toxicity at MTD according to NCI CTC 3.0

- Progression-free survival and Overall Survival

Study Design

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

Conditions

Locally Advanced Pancreatic Cancer

Intervention

gemcitabine, oxaliplatin, capecitabine

Location

Cantonal Hospital Bruderholz
Bruderholz
BL
Switzerland

Status

Completed

Source

University Hospital, Basel, Switzerland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:16:02-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).

Star-shaped, myofibroblast-like cells located in the periacinar, perivascular, and periductal regions of the EXOCRINE PANCREAS. They play a key role in the pathobiology of FIBROSIS; PANCREATITIS; and PANCREATIC CANCER.

An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.

A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.

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