Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

Breast Cancer Clinical Trial

Official title: An Open-Label Phase I Dose Escalation Trial To Evaluate The Safety And Pharmacokinetics Of Motexafin Gadolinium And Doxorubicin Chemotherapy In The Treatment Of Advanced Malignancies

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Motexafin gadolinium may increase the effectiveness of doxorubicin by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of combining motexafin gadolinium with doxorubicin in treating patients who have recurrent or metastatic cancer.

Clinical Trial Description

OBJECTIVES:

• Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.

• Determine the dose-limiting toxicity of this regimen in these patients.

• Determine the safety and tolerability of this regimen in these patients.

• Determine the pharmacokinetics of this regimen in these patients.

• Evaluate the tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 2 groups.

Group A:

• Course 1: Patients receive motexafin gadolinium IV over 30 minutes on days 1, 8, 9, and 10 and doxorubicin IV over 15 minutes on day 8.

• Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes.

• Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3. Treatment repeats every 21 days.

Group B:

• Course 1: Patients receive motexafin gadolinium IV over 30 minutes on day 1 and doxorubicin IV over 15 minutes on day 8.

• Course 2: 28 days after the beginning of course 1, patients receive doxorubicin IV over 15 minutes on day 1 and motexafin gadolinium IV over 30 minutes on days 1-3.

• Courses 3-6: Beginning 21 days after course 2, patients receive doxorubicin and motexafin gadolinium as in group A.

Treatment in both groups continues for up to 6 courses in the absence of disease progression, unacceptable toxicity, or a cumulative doxorubicin dose of 450 mg/m^2.

Cohorts of 3-6 patients receive escalating doses of doxorubicin and motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 0 of 3 or 1 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 and 2 months.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for this study. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Myeloproliferative Disorders
• Colorectal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Intestinal Neoplasms
• Leukemia
• Lung Cancer
• Lung Neoplasms
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Prostate Cancer
• Prostatic Neoplasms
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00036790
• Study type: Interventional
• Source: University of Wisconsin, Madison
• Status: Completed
• Phase: Phase 1
• Start date: February 2002