Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)

Breast Cancer Clinical Trial

Official title: A Phase I With Dose Expansion to Determine the Maximum Tolerated Dose of Liposomal Doxorubicin in Combination With Seliciclib for the Treatment of Patients With Metastatic Triple Negative Breast Cancer

Status Withdrawn

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.

Clinical Trial Description

The Study Drugs:

Seliciclib is designed to stop cancer cells from dividing, which may cause them to die.

Doxorubicin is a chemotherapy drug that is designed to stop the growth of cancer cells, which may cause the cells to die. Liposomal doxorubicin is a redesigned version of doxorubicin. The drug, doxorubicin, is enclosed in a fat bubble called a liposome. This is designed to allow the drug to get into the tumor tissue better and to stay in the body for a longer time.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of seliciclib based on when you joined this study. Up to 6 dose levels of seliciclib will be tested. At least 2 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 seliciclib is found.

All participants will receive the same dose level of liposomal doxorubicin.

Drug Administration:

You will take seliciclib by mouth with a cup (8 ounces) of water twice a day on Days 1-3 of each 28-day study cycle. The 2 doses should be taken 12 hours apart. Seliciclib should be taken 1 hour before or 2 hours after a meal. If you miss a dose, it can be taken up to 2 hours after the scheduled time. If it has been more than 2 hours, the missed dose should not be taken. You should resume taking the study drug at the next normally scheduled time.

You will receive liposomal doxorubicin by vein over 2-3 hours on Day 4 of each cycle.

On Days 5-28 you will not receive any study drugs.

Study Visits:

At all study visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.

On Day 1 of every cycle:

• You will have a physical exam, including measurement of your weight and vital signs.

• Your performance status will be recorded.

• Blood (about 1-2 teaspoons) and urine will be collected for routine tests.

During Week 2 of Cycle 1:

-Blood (about 1-2 teaspoons) will be drawn for routine tests.

You will have an ECHO or MUGA scan at least every 4 cycles to check your heart function.

After every even-numbered cycles (Cycles 2, 4, 6 and so on), you will have either a CT or MRI scan to check the status of the disease.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 4-6 weeks after you have stopped receiving the study drugs, you will have an end-of-study visit. The following tests and procedures will be performed:

• You will have a physical exam, including measurement of your weight and vital signs.

• Your performance status will be recorded.

• Blood (about 1-2 teaspoons) and urine will be collected for routine tests.

• You will be asked about any symptoms you may be having and drugs you may be taking.

This is an investigational study. Seliciclib is not FDA-approved or commercially available. It is currently being used for research purposes only.

Liposomal doxorubicin is FDA-approved and commercially available for metastatic breast cancer. The use of these drugs together is investigational.

Up to 40 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

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

• NCT number: NCT01333423
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2012