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

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ClinicalTrials.gov Identifier: NCT01219777
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : June 29, 2015
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ritu Salani, Ohio State University Comprehensive Cancer Center

October 11, 2010
October 13, 2010
May 6, 2015
June 29, 2015
February 8, 2018
September 2010
May 2012   (Final data collection date for primary outcome measure)
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.
Tolerated Dose [ Time Frame: 3 patients per dose level with minmum of 4 weeks observation period ]
To determine the maximum tolerated dose of carbplatin 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.
Complete list of historical versions of study NCT01219777 on ClinicalTrials.gov Archive Site
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.
Safety/Toxicity [ Time Frame: 3 patients per dose level, then minmum of 4 week observation period ]
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.
Not Provided
Not Provided
 
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
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
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.

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
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • 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
  • Drug: Bevacizumab
    Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
    Other Name: Avastin
  • 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
  • Experimental: Carboplatin
    AUC 5.0 or 6.0
    Intervention: Drug: carboplatin
  • Experimental: Bevacizumab
    15 mg/kg
    Intervention: Drug: Bevacizumab
  • Experimental: Paclitaxel
    60-80 mg/m2
    Intervention: Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
30
May 2015
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01219777
OSU-09149
NCI-2012-00512 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
Yes
Not Provided
Not Provided
Ritu Salani, Ohio State University Comprehensive Cancer Center
Ritu Salani
Genentech, Inc.
Principal Investigator: Ritu Salani, MD Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP