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Ovarian Cancer Clinical Trial - GOG0212
A randomized phase III trial of maintenance chemotherapy comparing
12 monthly cycles of single agent paclitaxel or OPAXIO™ (paclitaxel poliglumex, CT-2103; 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
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.
What is OPAXIO (paclitaxel
poliglumex, CT-2103)?
How is this ovarian cancer study conducted?
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: |
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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 |
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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 |
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Patients must have adequate bone marrow, liver and kidney
function and must no little to no peripheral neuropathy
(tingling and numbness in the extremities) |
Would you like more information about this ovarian cancer clinical
trial? Choose the cancer research clinical trial location nearest you:
Trials in the United States
Back to ovarian cancer trials
Posted May 20, 2008
Copyright © 2004-2008 Cell Therapeutics, Inc., Seattle,
WA, USA. All rights reserved. "Making cancer more treatable" is
a registered mark of CTI.
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