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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219777
• Other study ID #: OSU-09149
• Secondary ID: NCI-2012-00512
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2010
• Last updated: February 7, 2018
• Start date: September 2010
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cancer

Intervention

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.
• Bevacizumab
Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
• Paclitaxel
60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ritu Salani	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	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.	Up to 6 months

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