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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ritu Salani, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01219777
First received: October 11, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Drug: carboplatin
Drug: Bevacizumab
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Tolerated Dose [ Time Frame: 3 patients per dose level with minmum of 4 weeks observation period ] [ Designated as safety issue: Yes ]
    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:
  • Safety/Toxicity [ Time Frame: 3 patients per dose level, then minmum of 4 week observation period ] [ Designated as safety issue: Yes ]
    Determine the safety and toxicity of this regimen in this patient population.Assess the 30 day morbidity and mortality following surgical intervention. Describe response rate for patients treated with neoadjuvant chemotherapy using RECIST criteria and GCIG response criteria prior to surgical intervention.


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®
  • CBDCA
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histology,cytologically diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer
  • FIGO stage III or IV disease
  • GOG 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
  • Hepatic Function: SGOT and Alkaline Phosphate
  • Neurologic Function: Neuropathy less than CTCAE 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 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 28days 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 drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219777

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ritu Salani
Genentech, Inc.
Investigators
Principal Investigator: Ritu Salani, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Ritu Salani, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01219777     History of Changes
Other Study ID Numbers: OSU-09149, NCI-2012-00512
Study First Received: October 11, 2010
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
bevacizumab
paclitaxel
carboplatin
ovarian
cancer
fallopian tube
primary peritoneal

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 24, 2014