ONCONASE ® Plus Doxorubicin vs. Doxorubicin

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:

  • The safety of ONCONASE ® plus doxorubicin and any side effects that might be associated with the combination of these two drugs.

  • Whether ONCONASE ® plus doxorubicin can help patients with mesothelioma live longer.

  • Whether ONCONASE ® plus doxorubicin can make the tumor smaller or disappear, and for how long.

  • 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:

  • Adult patients with unresectable malignant mesothelioma.

  • Patients must have no more than one previous chemotherapy regimen (excluding doxorubicin). Prior surgery or radiation is allowed.

  • Patients must have an acceptable performance status.

  • Patients must have signed an informed consent.

Exclusion Criteria:

  • Patients who have received more than 1 prior systemic chemotherapy, or any prior treatment with doxorubicin.

  • Patients with symptomatic cardiovascular disease, congestive heart failure, angina pectoris, cardiac arrhythmia(s), or uncontrolled hypertension.

  • Patients with serious infections will be excluded until such infections are under control.

  • 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

*** POSTED ON AUGUST 16, 2005 ***