Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.
PRIMARY OBJECTIVE:
I. To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard
therapy (carboplatin and paclitaxel) (Arm II) increases the duration of progression-free
survival (PFS) when compared to 6 cycles of standard therapy alone (Arm I) in women with
newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian,
peritoneal primary or fallopian tube cancer.
II. To determine if the addition of 5 concurrent cycles of bevacizumab plus extended
bevacizumab for 16 cycles beyond the 6 cycles of standard therapy (carboplatin and
paclitaxel) (Arm III) increases progression-free survival when compared to 6 cycles of
standard therapy (Arm I) in women with newly diagnosed stage III (with any gross residual
disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.
SECONDARY OBJECTIVES:
I. In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with
respect to progression-free survival, to determine whether the Arm III regimen prolongs
progression-free survival when compared to the Arm II regimen.
II. To determine whether the Arm II or Arm III regimen increases the duration of overall
survival when compared with the Arm I regimen.
III. To compare each of the experimental regimens to the Arm I regimen with respect to the
incidence of severe toxicities or serious adverse events.
IV. To determine the impact on Quality of Life (QOL, as measured by the Functional Assessment
of Cancer Therapy-Ovarian [FACT-O] trial outcome index [TOI]) following treatment with the
above regimens.
TERTIARY OBJECTIVES:
I. To assess the relationship between angiogenic markers and clinical outcome including tumor
response, progression-free survival and overall survival in patients randomized to standard
cytotoxic chemotherapy (paclitaxel and carboplatin) without bevacizumab, with concurrent
bevacizumab or with extended bevacizumab.
II. To assess the predictive value of a set of genes whose expression correlates with
survival of patients with stage III (with any gross residual disease) and stage IV,
epithelial ovarian, peritoneal primary or fallopian tube cancer.
III. To bank whole blood for research. IV. To determine if genetic variations in genes
associated with essential hypertension including WNK lysine deficient protein kinase 1
(WNK1), G protein-coupled receptor kinase 4 (GRK4) and kallikrein B (KLKB1) predict which
patients are likely to develop bevacizumab-induced hypertension.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30
minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes
on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients
receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21
days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2,
patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21
days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90
minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the
absence of disease progression or unacceptable toxicity.
ARM III: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2,
patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21
days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90
minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
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