Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel Bevacizumab for Primary Ovarian

Brief Title

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

Official Title

Phase I Evaluation of Intravenous Carboplatin With Weekly Paclitaxel and Bevacizumab in Patients Undergoing Neoadjuvant Chemotherapy for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Brief Summary

      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.

Detailed Description

      Phase I study proposed to evaluate:

        -  Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant
           setting prior to surgery.

        -  Safety/Toxicity of IV regimen in this patient population

        -  Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab
           15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals
           of 10mg/m2 to a maximum dose of 80mg/m2.

        -  Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then
           cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6
           weeks of cycle 4.

        -  Post surgical treatment per physician discretion

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Tolerated Dose

Secondary Outcome

 Toxicity and Response Rates Based on Imaging and Surgical Outcomes

Condition

Ovarian Cancer

Intervention

carboplatin

Study Arms / Comparison Groups

 Carboplatin

Description:  AUC 5.0 or 6.0

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2010

Completion Date

May 2015

Primary Completion Date

May 2012

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

Gender

Female

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Ritu Salani, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01219777

Organization ID

OSU-09149

Secondary IDs

NCI-2012-00512

Responsible Party

Sponsor-Investigator

Study Sponsor

Ritu Salani

Collaborators

 Genentech, Inc.

Study Sponsor

Ritu Salani, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center

Verification Date

May 2015