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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
Bevacizumab
Paclitaxel
Sponsored by
Ritu Salani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring bevacizumab, paclitaxel, carboplatin, ovarian, cancer, fallopian tube, primary peritoneal

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Carboplatin

Bevacizumab

Paclitaxel

Arm Description

AUC 5.0 or 6.0

15 mg/kg

60-80 mg/m2

Outcomes

Primary Outcome Measures

Tolerated Dose
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.

Secondary Outcome Measures

Toxicity and Response Rates Based on Imaging and Surgical Outcomes
Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Full Information

First Posted
October 11, 2010
Last Updated
February 7, 2018
Sponsor
Ritu Salani
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01219777
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ritu Salani
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Keywords
bevacizumab, paclitaxel, carboplatin, ovarian, cancer, fallopian tube, primary peritoneal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carboplatin
Arm Type
Experimental
Arm Description
AUC 5.0 or 6.0
Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
15 mg/kg
Arm Title
Paclitaxel
Arm Type
Experimental
Arm Description
60-80 mg/m2
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin®, CBDCA
Intervention Description
Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Abraxane
Intervention Description
60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
Primary Outcome Measure Information:
Title
Tolerated Dose
Description
To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Toxicity and Response Rates Based on Imaging and Surgical Outcomes
Description
Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritu Salani, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

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

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