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Pancreaticoduodenectomy Plus Post-Op Chemo & Radiation in Resected Pancreatic Cancer

2014-08-27 03:16:28 | BioPortfolio

Summary

The goal of this clinical research study is to learn if the combination of 5-fluorouracil (5-FU), cisplatin, and interferon alfa-2b (Intron-A), given with radiation treatment, can help to prevent the growth of cancers in the pancreas. The safety of this combination treatment will also be studied.

Primary Objective:

-To evaluate the overall survival and toxicities observed in patients treated with the Virginia-Mason postoperative chemoradiation regimen.

Secondary Objective:

-To evaluate disease specific, biochemical failure-free, symptom/treatment-free survival, and quality of life in patients treated with the Virginia-Mason postoperative chemoradiation regimen.

Description

Before treatment starts, participants in this study will have a complete physical exam, including blood tests and a CT scan of the abdomen and pelvis. Blood samples will be taken once a week during treatment. About 2 tablespoons of blood will be drawn each time.

Participants in the study will receive external radiation therapy in the first phase of the treatment. The radiation therapy will be given externally (from outside the body) to a targeted area where the cancer is, or was, located. This procedure will use standard radiation techniques. This is a daily treatment, which will take about 5 minutes to complete. It will be performed every Monday through Friday for a total 6 1/2 weeks. In addition to the radiation treatment, participants will also receive three drugs during the first 45 days of treatment (Days 1-19 and 29-45).

The first drug that participants will receive is called 5-FU. It will be through a vein in the arm as a continuous infusion over 6 1/2 weeks. Before beginning therapy, a central venous catheter will be placed, either as a long line placed in the vein of the arm or a subclavian line (inserted under the collarbone). The 5-FU is infused using a small pump (an infusion pump) about the size of a transistor radio. The 5-FU is infused using a small pump (an infusion pump) about the size of a transistor radio. Participants will receive a total of three courses of 5-FU on Days 1-19 and 29-45, and then again on Days 71-108 and Days 127-168. The timing of the second and third courses of 5-FU could be delayed if there are interruptions in treatment (usually due to side effects) during the first course of 5-FU.

The second kind of drug that participants will receive is called cisplatin. Cisplatin will be given through a vein in the arm (over 60 minutes) once a week for a total of 6 doses. This will be done during the five and one-half weeks of radiation therapy. Participants will receive cisplatin on Days 1, 8, 15, 29, and 36, 43. Blood samples will be taken before each dose of cisplatin. About 2 tablespoons of blood will be drawn each time.

The third drug that participants will receive is called interferon alfa-2b (Intron-A). Intron-A is given subcutaneously (under the skin) every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45. This will continue for 6 1/2 weeks for a total of 17 doses. Some participants may be taught how to give the Intron-A to themselves. Vital signs (blood pressure and pulse rate) will be taken at each visit with the oncology team.

Participants will be evaluated before receiving any treatment and then weekly during treatment. During the weekly visit, participants will have blood samples taken to monitor blood (about two tablespoons for each sample), a physical exam, and will be asked about any side effects they may have experienced.

Participants will be taken off the study if the disease gets worse or intolerable side effects occur. After the treatment Days 1-19 and 29-45 are complete, participants will have a resting period of about four weeks before beginning the second cycle of 5-FU.

After the resting period at the beginning of week 10, participants will have a complete physical exam, blood tests (about two tablespoons), a CT of the abdomen and pelvis, a chest x-ray, and a nutritional evaluation before beginning the second cycle of 5-FU. The 5-FU infusions will be given on Days 71-108. There will be another four-week resting period with the same tests being done during week 18. The 5-FU will begin again on day 127-168.

Participants will be evaluated by a physician before each infusion of 5-FU on Days 71-108, on Days 127-168, and every 2 to 3 weeks. Clinical evaluations and laboratory tests will be done as needed.

After all therapy is complete, participants will be seen every 2-4 months for the first 2 years, every 3-5 months for the third year, and every 5-7 months for the 4th and 5th years (patients that are thought to have disease that has spread to other parts of the body may be seen earlier by their doctor to confirm that the disease has spread). From then on, follow-up will be done on a yearly basis. A medical history and physical exam, blood tests, a chest x-ray, and a CT scan of the abdomen and pelvis will be done at each follow-up visit.

This is an investigational study. All three of the drugs, 5-FU, cisplatin and Intron-A used in this study are FDA approved and commercially available. However, the use of these three agents together with radiation treatment is considered experimental. A total of 44 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

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

Conditions

Pancreas Cancer

Intervention

Radiation Therapy, Cisplatin, Intron-A (Interferon alfa-2b), 5-FU (5-fluorouracil)

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Active, not recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:28-0400

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Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

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