Bevacizumab, Erlotinib and Capecitabine for Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title: Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with radiation to patients with pancreatic cancer.

Clinical Trial Description

The Study Drugs:

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Capecitabine and erlotinib hydrochloride are designed to interfere with the growth of cancer cells.

Study Drug Dose Level:

If you are found to be eligible to take part in the study, you will begin receiving capecitabine, erlotinib hydrochloride, and bevacizumab. The dose you receive will be based on how many participants have been enrolled before you, and on the safety data that are available. The first group of enrolled participants will be given low doses of capecitabine, erlotinib hydrochloride, and bevacizumab. If no intolerable side effects occur, the next group will be enrolled at a higher dose level. This process will continue until researchers find the highest dose of capecitabine, erlotinib hydrochloride, and bevacizumab that can be given without intolerable side effects occurring. The study doctor will tell you what dose you will be receiving and how it compares to the doses other participants have received.

Study Drug Administration:

On Days 1, 14, and 28, you will receive bevacizumab through a needle in your vein. Your first infusion will last about 90 minutes. If you tolerate the drug well, the next infusion will last about 60 minutes. If the 60-minute infusion is well tolerated, all other infusions will last about 30 minutes.

On each day that you receive radiation, you will take capecitabine and erlotinib hydrochloride by mouth in the morning and evening with food.

Radiation:

You will receive radiation once a day on Monday through Friday, excluding holidays. This schedule will be continue for 5 1/2 weeks or 28 doses.

Study Visits:

Every week while you are on study, you will have the following tests and procedures performed:

• You will have a physical exam.

• Blood (about 2 teaspoons) will be drawn for routine tests.

• You will be asked about any side effects you may be experiencing.

• You will repeat the same health questionnaire that you filled out at screening.

Bevacizumab and Surgery:

If at any time during the study the tumor can be removed surgically, you will have surgery. A separate consent form would be used. Because bevacizumab may slow the healing of wounds, study participants may not have surgery within 10 weeks after the last bevacizumab infusion.

Length of Study:

You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the disease gets worse or intolerable side effects occur.

End-Of-Study Visit:

Four (4) to 6 weeks after you finish radiation, you will have an end-of-study visit with the following tests and procedures performed:

• You will have a complete physical exam.

• Blood (about 2 tablespoons) and urine will be collected for routine tests.

• You will have chest x-rays and CT scans of the abdomen.

• You will repeat the health questionnaire.

Additional Experimental Therapy:

If you appear to be benefitting from the experimental therapy, the study doctor may decide to continue your experimental therapy after the end-of-study visit. This would be daily erlotinib hydrochloride, with bevacizumab infusions every 2 weeks unless the disease gets worse or intolerable side effects occur. You would have study visits once a month, with the same procedures as you did during the weekly study visits (except for the questionnaires).

This is an investigational study. Capecitabine, bevacizumab, and erlotinib hydrochloride are FDA approved and commercially available. The use of capecitabine and bevacizumab for pancreatic cancer and in combination with erlotinib hydrochloride is investigational. At this time, the 3-drug combination is being used in research only.

Up to 30 patients will take part in the study. All will be enrolled at M. D. Anderson. ;

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00614653
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: January 2008
• Completion date: July 2016