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Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036790
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 17, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chronic Myeloproliferative Disorders Colorectal Cancer Head and Neck Cancer Leukemia Lung Cancer Lymphoma 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

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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : February 2002
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Nasopharyngeal Carcinoma Small Cell Lung Cancer Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Laryngeal Cancer Hypopharyngeal Cancer Hodgkin Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Hairy Cell Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Mycosis Fungoides Cutaneous T-cell Lymphoma Anaplastic Large Cell Lymphoma Myelodysplastic/myeloproliferative Disease Chronic Myeloproliferative Disorders Chronic Myeloid Leukemia Burkitt Lymphoma Oral Cancer Lip and Oral Cavity Cancer Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma Small Intestine Cancer Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia Metastatic Squamous Neck Cancer With Occult Primary

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036790

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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)
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Study Chair: Markus Renschler, MD Pharmacyclics LLC.
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00036790    
Other Study ID Numbers: CDR0000069322
P30CA014520 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: September 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:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Head and Neck Neoplasms
Intestinal Neoplasms
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
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
Prostatic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases