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Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
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
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.

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  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
Intervention  Drug: doxorubicin hydrochloride
Drug: motexafin gadolinium
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  February 2002
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00036790
Organization ID CDR0000069322
Secondary IDs †† WCCC-CO-01910, PCI-PCYC-0207, NCI-G02-2061
Study Sponsor  University of Wisconsin, Madison
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Markus Renschler, MD     Pharmacyclics    
Information Provided By National Cancer Institute (NCI)
Verification Date September 2004
First Received Date  May 13, 2002
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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