Phase I-II for Patients With Recurrent or Refractory Non-small Cell Lung Cancer (NSCLC)

Lung Cancer Clinical Trial

Official title: Phase I-II Study of Avastin®+ Bortezomib for Patients With Recurrent or Refractory Non-Squamous NSCLC

Status Withdrawn

Clinical Trial Summary

Primary Objective

The primary objective of this phase I-II study is to evaluate:

• Phase I: Assess the maximum tolerated dose (MTD) of bortezomib in a weekly schedule with bevacizumab given every 3 weeks.

• Phase II: Using the MTD established in phase I, assess efficacy of the combination as indicated by progression-free survival.

Secondary Objectives

The secondary objectives of this study are to evaluate:

• Response rates and duration of response

• 1 year survival

• Overall survival

• Qualitative and quantitative toxicity

• Circulating endothelial cells (CECs) prior to treatment, prior to cycle 2, and/or at the time of progression

Clinical Trial Description

Bortezomib is designed to enter cells and interfere with a substance found inside cells that is responsible for allowing cells to divide.

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

If you are found to be eligible to take part in this study, depending on when you enroll, you will be assigned to one of up to 4 treatment groups. There will be 3 participants in each of the first few groups, and an additional 30 participants in the last group. The first few (2 or 3) groups are part of the first phase of the study, and the last group (3rd or 4th) is part of the second phase. All participants will receive the same dose level of Avastin®. The amount of bortezomib you receive will depend on when you enroll in the study. The exact dose of bortezomib that you receive will be based on your height and weight. In the first phase of the study, groups of participants will be assigned to one of 2 bortezomib dose levels. The first group will receive the highest dose. The next groups will receive either that same dose level, or if intolerable side effects occurred, a lower dose level. For the second part of the study, the last group will receive the highest dose level that did not cause intolerable side effects in the other groups.

A cycle of treatment is 3 weeks (21 days). Bortezomib will be given once a week for the first 2 weeks of each cycle. Avastin® will be given every 3 weeks. (On Day 1 of each cycle, you will receive both bortezomib and Avastin®.)

Bortezomib will be injected through a needle in your vein. Each injection will last about 3-5 seconds. After receiving each dose of bortezomib, the clinic staff will check how well you are tolerating the drug. During that time, you will be asked about any side effects you may be experiencing. Your doctor may decrease or pause the dose of bortezomib if you experience certain side effects.

Avastin® will be given as an infusion through a needle in your vein, over 90 minutes. If you tolerate the 90-minute infusion well, the second infusion will be given over 60 minutes. If you tolerate the 60-minute infusion well, all following infusions will be given over 30 minutes. If you do not tolerate the shorter infusion time, future infusion times will be increased until a tolerable level is reached.

Every 3 weeks, you will have a physical exam, including measurement of vital signs and weight. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation. On Day 8 of each cycle of treatment, blood (about 2 teaspoons) will be drawn for routine tests. The level of protein in your urine will be monitored at least every 6 weeks.

You may continue receiving study treatment for as long as the cancer responds to the treatment or for up to 1 year. Your doctor may decide to take you off this study if you experience intolerable side effects or your health gets worse.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) will be drawn for routine tests. You will have a performance status evaluation, chest x-ray, and a CT or MRI scan. On an indefinite basis, the study nurse will contact you by telephone from time to time to see how you are doing.

This is an investigational study. Bortezomib has been FDA approved and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy. Avastin® has been FDA approved for the treatment of metastatic colorectal cancer and non-small cell lung cancer. However, bortezomib and Avastin® are not FDA-approved for this type of cancer, and they have been authorized for use together in research only. Up to 42 patients will take part in this 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

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00411593
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: November 2006
• Completion date: May 2007