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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219777
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : June 29, 2015
Last Update Posted : February 8, 2018
Genentech, Inc.
Information provided by (Responsible Party):
Ritu Salani, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Drug: carboplatin Drug: Bevacizumab Drug: Paclitaxel Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Carboplatin
AUC 5.0 or 6.0
Drug: carboplatin
Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
Other Names:
  • Paraplatin®

Experimental: Bevacizumab
15 mg/kg
Drug: Bevacizumab
Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
Other Name: Avastin

Experimental: Paclitaxel
60-80 mg/m2
Drug: Paclitaxel
60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
Other Names:
  • Taxol
  • Abraxane

Primary Outcome Measures :
  1. Tolerated Dose [ Time Frame: Up to 6 months ]
    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 :
  1. Toxicity and Response Rates Based on Imaging and Surgical Outcomes [ Time Frame: Up to 6 months ]
    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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219777

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ritu Salani
Genentech, Inc.
Principal Investigator: Ritu Salani, MD Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: Ritu Salani, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT01219777     History of Changes
Other Study ID Numbers: OSU-09149
NCI-2012-00512 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: October 13, 2010    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: February 8, 2018
Last Verified: May 2015

Keywords provided by Ritu Salani, Ohio State University Comprehensive Cancer Center:
fallopian tube
primary peritoneal

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors