Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian

Completed · Phase 1

Conditions studied: Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

In brief

The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo surgery which will allow an objective measure of response to the above regimen as well as assessment of surgical outcomes.

Key facts

Study ID

NCT01219777

Run by

Ritu Salani

People needed

9

Starts

2010-09-01

Expected to finish

2015-05-01

Last updated by the study team

2018-02-08

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
• FIGO (International Federation of Gynecology and Obstetrics stage III or IV disease
• GOG (Gynecologic Oncology Group) Performance Status 0,1,2
• No prior surgery for their malignancy
• Adequate bone marrow function
• Platelet count greater than or equal to 100,000
• Renal Function: Creatinine < 1.5 institutional upper limit normal
• Hepatic Function: Bilirubin less than 1.5 ULN (upper limit of normal)
• Hepatic Function: SGOT (serum glutamate oxaloacetate transaminase) and Alkaline Phosphate
• Neurologic Function: Neuropathy less than CTCAE (Common Toxicity Criteria for Adverse Effects)grade 1
• Coagulation Functions: INR<1.5 and PTT ,1.2 times the upper limit of normal
• Measurable disease

You may not qualify if…

• Previous cancer related surgery
• Received prior chemotherapy, immunotherapy, radiotherapy, hormonal therapy or biologic therapy for their ovarian, fallopian tube or primary peritoneal cancer.
• Borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian are not eligible.
• Other cancers within 5 years (other than non-melanoma skin cancer)
• Acute Hepatitis or end stage liver disease
• History of prior gastrointestinal perforation
• Evidence of abdominal free air not explained by paracentesis
• Sign or symptoms of gastrointestinal obstruction
• Active bleeding or pathologic conditions that carry high risk of bleeding
• CNS (Central Nervous System) disease
• Clinically Significant cardiovascular disease
• Known hypersensitivity to Chinese Hamster ovary cell products or other recombinant human or humanized antibodies
• Clinically significant proteinuria.
• Hypertensive crises or hypertensive encephalopathy
• History of hemoptysis
• Any non-study related invasive procedure within 28 days fo first date of bevacizumab
• GOG performance status 3 or 4
• Patients who are pregnant or nursing.
• Under the age of 18
• Received prior treatment of bevacizumab or any anti-VEGF (vascular endothelial growth factor) drug

Where it is running

• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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