Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
David O'Malley
With
Genentech, Inc.
Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of patients.
Age
18–90
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery.
* All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation
GOG(Gynecologic Oncology Group)performance status of 0,1,2
Entered within 12 weeks of most recent surgery performed for diagnosis.
Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits
Sign approved consent form.
You may not be if
Patients who have received prior treatment other than initial surgery
Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis
Patients with acute hepatitis or active infection
Patients with active bleeding
Patients with unstable angina
Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer.
Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer.
Patients with synchronous primary endometrial cancer.
Patients with epithelial tumors of low malignant potential
Serious non healing wound, ulcer or bone fracture.
Patients with history or evidence of CNS(central nervous system disease)
Patients under 18 years old.
Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor)
drug, bevacizumab
Patients who have a history of allergic reaction to polysorbate 80.
