Trial Outcomes & Findings for Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian (NCT NCT01219777)

NCT ID: NCT01219777

Last Updated: 2018-02-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

9 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2018-02-08

Participant Flow

Patients were enrolled from January to December 2011.

Patients with a histologically or cytologically confirmed EOC with radiographic evidence of advanced disease, consistent with FIGO stage IIIC or IV.

Participant milestones

Participant milestones
Measure	Carboplatin + Weekly Paclitaxel and Bevacizumab * Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days. * Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4. * Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab. * Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=9 Participants * Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days. * Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4. * Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab. * Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 patients n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Outcome measures

Outcome measures
Measure	Arm I n=9 Participants * Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days. * Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4. * Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab. * Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of
Tolerated Dose	80 mg/m^2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm I n=9 Participants * Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days. * Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4. * Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab. * Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of
Toxicity and Response Rates Based on Imaging and Surgical Outcomes Partial Responses	9 patients
Toxicity and Response Rates Based on Imaging and Surgical Outcomes Dose Limiting Toxicities	0 patients
Toxicity and Response Rates Based on Imaging and Surgical Outcomes Optimal debulking achieved	9 patients

Adverse Events

Arm I

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I n=9 participants at risk * Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days. * Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4. * Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab. * Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of
Blood and lymphatic system disorders Neutropenia	44.4% 4/9 • Number of events 4 • Up to 6 months The NCI Common Terminology Criteria for Adverse Events version 4.0 was used for toxicity assessment for patients.
Vascular disorders Venous thromboembolic disease	22.2% 2/9 • Number of events 2 • Up to 6 months The NCI Common Terminology Criteria for Adverse Events version 4.0 was used for toxicity assessment for patients.
Nervous system disorders Syncope	11.1% 1/9 • Number of events 1 • Up to 6 months The NCI Common Terminology Criteria for Adverse Events version 4.0 was used for toxicity assessment for patients.

Additional Information

Ritu Salani, MD, MBA

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place