Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00036790
First received: May 13, 2002
Last updated: September 30, 2015
Last verified: September 2015
  Purpose

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
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

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:

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

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • No concurrent surgery

Other:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036790

Locations
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)
Investigators
Study Chair: Markus Renschler, MD Pharmacyclics
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00036790     History of Changes
Other Study ID Numbers: CDR0000069322  P30CA014520  WCCC-CO-01910  PCI-PCYC-0207  NCI-G02-2061 
Study First Received: May 13, 2002
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

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:
Lymphoma
Leukemia
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Colorectal Neoplasms
Head and Neck Neoplasms
Plasmacytoma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
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

ClinicalTrials.gov processed this record on August 29, 2016