Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry WCCC-CO-01910 PCI-PCYC-0207, NCI-G02-2061, NCT00036790

Objectives

1. Determine the maximum tolerated dose of motexafin gadolinium and doxorubicin in patients with advanced malignancies.
2. Determine the dose-limiting toxicity of this regimen in these patients.
3. Determine the safety and tolerability of this regimen in these patients.
4. Determine the pharmacokinetics of this regimen in these patients.
5. Evaluate the tumor response in patients treated with this regimen.

Entry 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

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/m²
• 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

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/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 3-48 patients will be accrued for this study.

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/m².

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.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Markus Renschler, MD, Protocol chair		Ph: 408-774-3366

Registry Information
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
Trial Start Date		2002-02-06
Registered in ClinicalTrials.gov		NCT00036790
Date Submitted to PDQ		2002-03-06
Information Last Verified		2004-09-10
NCI Grant/Contract Number		P30-CA14520

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