Ovarian Cancer Clinical Trial: GOG0212

Now Enrolling

A randomized phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or OPAXIO™ (formerly known as XYOTAX) versus no treatment until documented relapse in women with advanced ovarian or primary peritoneal cancer who achieve a complete clinical response to primary platinum/taxane chemotherapy.

How Is this Ovarian Cancer Study Conducted?

The primary objectives of this study are to determine whether OPAXIO™ or paclitaxel, administered to women with advanced ovarian cancer who have attained a clinically-defined complete response to primary platinum/taxane chemotherapy, will reduce the death rate, compared to retreatment at the time of documented disease progression. And to determine if, in this clinical setting, OPAXIO™ produces a more favorable toxicity profile and superior quality of life compared to paclitaxel.

Patients diagnosed with primary peritoneal cancer or stage III or IV ovarian cancer who have no symptoms suggestive of persistent cancer, normal physical exam, normal CT scan of the abdomen/pelvis and serum CA-125 antigen level after receiving 4 to 6 cycles of platinum-taxane therapy will be randomized to: OPAXIO™ every 28-days for 12 months, OR paclitaxel every 28-days for 12 months, OR no further treatment until evidence of disease progression.

Who Can Participate in this Ovarian Cancer Clinical Trial?

The following criteria (along with other technical criteria) must be evaluated by the study physician:

• Diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, All patients must have had appropriate surgery for ovarian or peritoneal carcinoma
• Patients must have completed treatment within the past 6 weeks with at least 5 cycles and not more than 6 cycles of carboplatin and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer
• Patients must have adequate bone marrow, liver and kidney function and must no little to no peripheral neuropathy (tingling and numbness in the in the extremities)