Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin; Motexafin gadolinium

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