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.

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