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RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer

2014-08-27 03:16:19 | BioPortfolio

Summary

Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators interfere with the VEGF pathway, the investigators inhibit this blood vessel growth which is required by tumors. One of the study drugs being used, AV-951, selectively interferes with the VEGF pathway. The second study drug being used is called RAD001. RAD001 interferes with the mTOR pathway. The mTOR pathway is another pathway involved in blood vessel and tumor cell growth. By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease.

Description

- Since we are looking for the highest dose of the study drug that can be given safely without severe or unmanageable side effects in participants with gastrointestinal malignancies, not everyone who participates will receive the same dose of the study drug. The dose will depend on the number of participants who have enrolled and how well they tolerated their doses.

- Both RAD001 and AV-951 are pills that are taken orally. Each treatment cycle lasts 4 weeks during which time participants will be taking: RAD001: once a day, every day and AV-951: once a day for 3 weeks followed by a 1 week break.

- Participants will be given a take home blood pressure machine and be instructed on how to use it. They will be asked to keep a daily blood pressure diary.

- During all cycles participants will have a physical exam (including vital signs) and be asked questions about their general health and specific questions about any problems they may be experiencing.

- Every 8 weeks the tumor will be assessed by CT scan (or imaging tests).

- Blood tests will be done every other week while the participant is on study and a urine test will be done every 4 weeks while the participant is on study.

Study Design

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

Conditions

Gastrointestinal Cancer

Intervention

RAD001, AV-951

Location

Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115

Status

Recruiting

Source

Dana-Farber Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:19-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the GASTROINTESTINAL TRACT, from the MOUTH to the ANAL CANAL.

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)

Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion.

A glycoprotein that is secreted into the luminal surface of the epithelia in the gastrointestinal tract. It is found in the feces and pancreaticobiliary secretions and is used to monitor the response to colon cancer treatment.

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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