http://www.centerwatch.com/patient/studies/stu80986.html
Summary: ONCONASE ® plus doxorubicin vs. doxorubicin for
patients with Malignant Pleural or Peritoneal Mesothelioma who have had no
more than one prior chemotherapy regimen.
The purposes of this study are to determine:
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The safety of ONCONASE ® plus doxorubicin and any side effects that
might be associated with the combination of these two drugs.
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Whether ONCONASE ® plus doxorubicin can help patients with
mesothelioma live longer.
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Whether ONCONASE ® plus doxorubicin can make the tumor smaller or
disappear, and for how long.
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Whether patients feel better while taking ONCONASE ® plus
doxorubicin.
Patients who have taken Alimta may be eligible. Treatment duration will
be at least 18 weeks.
Inclusion Criteria:
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Adult patients with unresectable malignant mesothelioma.
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Patients must have no more than one previous chemotherapy regimen
(excluding doxorubicin). Prior surgery or radiation is allowed.
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Patients must have an acceptable performance status.
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Patients must have signed an informed consent.
Exclusion Criteria:
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Patients who have received more than 1 prior systemic chemotherapy,
or any prior treatment with doxorubicin.
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Patients with symptomatic cardiovascular disease, congestive heart
failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled
hypertension.
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Patients with serious infections will be excluded until such
infections are under control.
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Patients with uncontrolled psychiatric disorders or neurologic
diseases.
Please note that more specific inclusion / exclusion criteria must be
met prior to entering this trial.
Contact:
Marie Fuerst, Study Coordinator
Tower Hematology Oncology Medical Group
9090 Wilshire Blvd., Second Floor
Beverly Hills, CA 90211
Telephone: 310-888-8680
Fax: 310-285-7298
Email:
FuerstM@toweroncology.com
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