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Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: May 13, 2002
Last updated: September 30, 2015
Last verified: September 2015

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.

Condition Intervention Phase
Breast Cancer
Chronic Myeloproliferative Disorders
Colorectal Cancer
Head and Neck Cancer
Lung Cancer
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic/Myeloproliferative Diseases
Prostate Cancer
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: doxorubicin hydrochloride
Drug: motexafin gadolinium
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Study Start Date: February 2002
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced malignancy that is considered incurable

    • Recurrent or metastatic disease
    • Relapsed solid tumors include, but are not limited to the following sites:

      • Lung
      • Breast
      • Colon
      • Prostate
      • Head and neck
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Not specified

Menopausal status

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • LVEF greater than 45% at rest
  • No prior myocardial infarction
  • No congestive heart failure
  • No clinically significant ventricular arrhythmias


  • No history of HIV infection
  • No history of porphyria
  • No glucose-6-phosphate dehydrogenase deficiency
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation


Biologic therapy:

  • Not specified


  • At least 28 days since prior chemotherapy
  • No prior lifetime cumulative doxorubicin exposure of more than 300 mg/m^2
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Not specified


  • At least 28 days since prior radiotherapy
  • No concurrent radiotherapy


  • No concurrent surgery


  • At least 14 days since prior multidrug resistance-modulating drugs (e.g., PSC833 or cyclosporine)
  • No other concurrent antineoplastic or investigational agents
  Contacts and Locations
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Please refer to this study by its identifier: NCT00036790

United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Study Chair: Markus Renschler, MD Pharmacyclics LLC.
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00036790     History of Changes
Other Study ID Numbers: CDR0000069322
P30CA014520 ( US NIH Grant/Contract Award Number )
Study First Received: May 13, 2002
Last Updated: September 30, 2015

Keywords provided by University of Wisconsin, Madison:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
refractory hairy cell leukemia
chronic myelomonocytic leukemia
T-cell large granular lymphocyte leukemia
acute undifferentiated leukemia
stage III grade 1 follicular lymphoma

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Head and Neck Neoplasms
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases processed this record on May 24, 2017