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Dual REctcal Angiogenesis or MEK Inhibition radioTHERAPY Trial

2014-08-27 03:12:17 | BioPortfolio

Summary

To determine the maximum tolerated dose (MTD) of AZD6244 or AZD2171 when combined with pre-operative capecitabine and radiotherapy in patients with locally advanced rectal cancer.

Description

The best curative resection rates reported for patients with operable rectal cancer treated with standard chemoradiotherapy are approximately 50-60%.The pathological complete response rates are only 10-20%. Therefore, there is a need for more effective treatment. In this trial we will evaluate the combination of chemoradiotherapy with either a VEGFR (vascular endothelial growth factor receptor) or MEK (MAP Kinase)inhibitor.

Aims

1. Define the tolerability, MTD (maximum tolerated dose) and DLT (dose limiting toxicities) of chemoradiotherapy in combination with

- cediranib, a VEGF receptor tyrosine kinase inhibitor that inhibits angiogenesis or

- AZD6244, a potent MEK inhibitor that inhibits cell proliferation

2. Define a dose suitable for phase II evaluation

3. Test the impact of the combination on soluble and imaging (FLT-PET and DCEMRI/DWI) biomarkers to guide their use in phase II testing Summary Patients will receive standard chemoradiotherapy plus ascending doses of AZD6244 or cediranib from day -10 (relative to start of chemoradiotherapy) to day 35. If feasible, patients' tumours will be resected 10-12 weeks after treatment. Translational studies on available tissue and blood will be performed and DCE-MRI/DWI and FLT-PET will be carried out on 5 patients in the expanded cohort for AZD6244 (FLT-PET and DCE-MRI) and 5 patients in the expanded cohort for cediranib (DCE-MRI).

Cohorts Cediranib - 15mg od, 20mg od and 30mg od AZD6244 - 50mg bd and 75mg bd

Study Design

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

Conditions

Rectal Cancer

Intervention

AZD6244, Cediranib (AZD2171)

Location

The Christie NHS Foundation Trust
Manchester
United Kingdom
M20 4BX

Status

Not yet recruiting

Source

Christie Hospital NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:17-0400

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Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.

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PubMed Articles [13418 Associated PubMed Articles listed on BioPortfolio]

The Rectal Cancer Female Sexuality Score: Development and Validation of a Scoring System for Female Sexual Function After Rectal Cancer Surgery.

Sexual dysfunction and impaired quality of life is a potential side effect to rectal cancer treatment.

Benchmarking rectal cancer care: institutional compliance with a longitudinal checklist.

In 2012, the American Society of Colon and Rectal Surgeons published the Rectal Cancer Surgery Checklist, a consensus document listing 25 essential elements of care for all patients undergoing radical...

Improving the Quality of MRI Reports of Preoperative Patients With Rectal Cancer: Effect of National Guidelines and Structured Reporting.

Since the implementation of new guidelines for rectal cancer in The Netherlands in April 2014, clinical stage as seen at preoperative MRI indicates whether neoadjuvant therapy is necessary before rect...

Laparoscopic Abdominal Transanal Proctocolectomy with Coloanal Anastomosis Is a Good Surgical Option in Selective Patients with Low-Lying Rectal Cancer: A Retrospective Analysis Based on a Single Surgeon's Experience.

We intended to identify the oncological outcome for rectal cancer over the past 20 years and whether or not sphincter-preserving surgery is an appropriate approach for low-lying rectal cancer.

Laparoscopic surgery after neoadjuvant therapy in elderly patients with rectal cancer.

The standard treatment for mid or low locally advanced rectal cancer is neoadjuvant therapy followed by surgical resection. Laparoscopic surgery has recently been applied for the treatment of rectal c...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the RECTUM.

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A compound tubular gland, located around the eyes and nasal passages in marine animals and birds, the physiology of which figures in water-electrolyte balance. The Pekin duck serves as a common research animal in salt gland studies. A rectal gland or rectal salt gland in the dogfish shark is attached at the junction of the intestine and cloaca and aids the kidneys in removing excess salts from the blood. (Storer, Usinger, Stebbins & Nybakken: General Zoology, 6th ed, p658)

Protrusion of the rectal mucous membrane through the anus. There are various degrees: incomplete with no displacement of the anal sphincter muscle; complete with displacement of the anal sphincter muscle; complete with no displacement of the anal sphincter muscle but with herniation of the bowel; and internal complete with rectosigmoid or upper rectum intussusception into the lower rectum.

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

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