Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer (NCT00036790) | Clinical Trial Compass
CompletedPhase 1
Motexafin Gadolinium and Doxorubicin in Treating Patients With Advanced Cancer
United StatesStarted 2002-02
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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
Ra…