Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

Advanced Cancer Clinical Trial

Official title: A Phase I Trial of Bevacizumab and Temsirolimus in Patients With Advanced Malignancy

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.

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 that supply nutrients necessary for tumor growth.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of bevacizumab and temsirolimus combined, based on when you joined this study. Up to 13 dose levels of the study drug combination will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

If you choose to enroll in the expansion group of patients being treated at the highest tolerable dose of the study drug combination found, you will be required to undergo added testing, as follows:

• You will have additional blood drawn (about 2 teaspoons each time) during Cycle 1. This blood will be drawn before you begin taking the study drugs; on Day 1 at about 1, 4, 8, and 24 hours after the start of your first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at the end of Cycle 1. The blood will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells.

• You will have 2 tumor biopsies performed. These samples will be used to see how the study drug combination acts in the body and to learn its effect on cancer cells. These tumor biopsies will be performed during the screening visit and at the end of Cycle 1. To perform a tumor biopsy, the affected area is numbed with anesthetic and some or all of the tumor tissue is removed with a small knife.

• You will have extra imaging scans performed and used to see how the study drug combination may be affecting blood vessels that supply nutrients and oxygen to cancer. A DCE-MRI scan will be performed during the screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1. Like a regular MRI scan, the DCE-MRI scan involves passing part or all of the body into a long, narrow tube scanner that is open at both ends.

Study Drug Administration:

Bevacizumab and temsirolimus will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.

Bevacizumab is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 90 minutes. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 30 minutes in Cycle 3. It will continue to be given over 30 minutes in Cycle 4 and further cycles, as long as you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Bevacizumab in the doctor's office in or near your hometown.

Temsirolimus is given by vein on Days 1, 8, and 15 of each cycle. During Day 1 of Cycle 1, you will receive it over 60 minutes. If you tolerate it well on Day 1 of Cycle 1, it will be given over 30 minutes on Days 8 and 15 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well. Also, if the first dose is well tolerated, you may be given the remaining doses of Temsirolimus in the doctor's office in or near your hometown.

Study Visits:

You will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once between Days 7 and 14 during Cycle 1. During the rest of the cycles, you will have a physical exam and blood drawn (about 1 tablespoon each time) for routine tests once every 3 weeks. The status of the disease will be checked by a CT or MRI scan after every 2 cycles, starting after Cycle 2.

Length of Study Participation:

You may continue to receive additional cycles of the study drugs, unless the cancer gets worse or intolerable side effects occur. In that case, you will be taken off study.

Once your participation is over in this study, you will receive standard-of-care follow-up for the disease.

This is an investigational study. Bevacizumab and temsirolimus are commercially available. Bevacizumab is FDA approved for the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved for the treatment of kidney cancer that has spread. The combination of bevacizumab and temsirolimus is not FDA approved. At this time, it is being used in research only.

Up to 183 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Advanced Cancer

• NCT number: NCT00610493
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: January 25, 2008
• Completion date: November 28, 2017