A Randomized Controlled Study of YONDELIS (Trabectedin) or Darcarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
-To evaluate whether overall survival for the trabectadin group is superior to the dacarbazine group for subjects with advance leiomyosarcoma or liposarcoma who were previously treated with an anthracycline and ifosfamide. -To evaluate progression-free survival, time to progression, objective response rate, symptom severity, and safety in the trabectadin group and dacarbazine group.
Patients must be at least 15 years of age or older with histologically proven, unresectable, locally advanced or metastatic leiomyosarcoma or liposarcoma. Patient must have been treated with an anthracycline (doxorubicin, adriamycin, doxil, liposomal doxorubicin) and an ifosfamide either in combination or as sequential regimens. Patients must have measurable disease. Patients must have good organ function with good blood counts and be up and out of bed/active in daily living activities for at least 75% of the day. Pregnant/breast-feeding patients will be excluded. Strict contraceptive precautions are mandatory. Patient must have completed prior systemic chemotherapy, radiation therapy, or other investigational therapy at least 3 weeks prior to enrolling on this study. Patients with known central nervous system metastasis will be excluded. Patients with active liver disease (chronic viral hepatitis or cirrhosis) will be excluded. Patient must be willing to have a central venous catheter placed in order to have drug administered safely. Patients who have had a myocardial infarction (heart attach) within 6 months before enrolling on this study will be excluded. Patient must be willing and able to travel to and from clinic frequently, and to adhere to all study tests/procedures required.
After signing written informed consent, patient will be required to undergo a series of tests to determine eligibility for the trial (blood work, scans, echocardiogram/MUGA, EKG, physical exam). Once patient is deemed eligible, patient will be randomized (like the flip of a coin) to receive either Trabectadin IV as a 24 hour infusion on Day 1 of each 21 day cycle OR Dacarbazine IV as a 20 minute infusion on Day 1 of each 21 day cycle. This is an outpatient treatment-based study. Those randomized to the Trabectadin treatment arm will receive a 24 hour infusion of drug via a home infusion pump. Those randomized to the Dacarbazine group will come to the clinic to receive their medication. Patients will have CT Scan/MRI performed approximately every 2 months. Those who have stable disease, or response, will continue on study indefinitely so long as the disease is stabilized or shrinking. Patients will come OFF study therapy when disease progression is documented. For those patients randomized to the Dacarbazine arm who have progressed, there is NO cross-over to the Trabectadin arm. Frequent visits to clinic will be required for blood work, physical exams, nurse/doctor visits, and other tests as applicable to the study protocol.
05/19/2013 04:02 AM