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Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00036790
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
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:

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.


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

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 ClinicalTrials.gov identifier (NCT number): NCT00036790


Locations
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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)
Investigators
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Study Chair: Markus Renschler, MD Pharmacyclics LLC.

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00036790     History of Changes
Other Study ID Numbers: CDR0000069322
P30CA014520 ( U.S. NIH Grant/Contract )
WCCC-CO-01910
PCI-PCYC-0207
NCI-G02-2061
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Keywords provided by University of Wisconsin, Madison:
unspecified adult solid tumor, protocol specific
recurrent non-small cell lung cancer
recurrent small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent lip and oral cavity cancer
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent metastatic squamous neck cancer with occult primary
recurrent hypopharyngeal cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent laryngeal cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms, Plasma Cell
Colorectal Neoplasms
Head and Neck Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Lymphoma
Leukemia
Multiple Myeloma
Plasmacytoma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Breast Diseases
Skin Diseases
Lung Diseases
Respiratory Tract Diseases