Neoadjuvant Chemotherapy IV Carboplatin With Weekly Pacli... | NCT01219777

NCT01219777

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
NCI-2012-00512	Registry Identifier	Clinical Trials Reporting Program (CTRP)

Status Module

Name	Class
Genentech, Inc.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Carboplatin	Experimental	AUC 5.0 or 6.0	Drug: carboplatin
Bevacizumab	Experimental	15 mg/kg	Drug: Bevacizumab
Paclitaxel	Experimental	60-80 mg/m2	Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carboplatin	Drug	Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.	Carboplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Ritu Salani, MD	Ohio State University Comprehensive Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University Medical Center		Columbus	Ohio	43210	United States

Label	URL
Jamesline	View source

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Arm I	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

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Number

mg/m^2

Up to 6 months

ID	Title	Description
OG000	Arm I	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm I	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

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms
D009369	Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases

ID	Term
D016190	Carboplatin
D000068258	Bevacizumab
D017239	Paclitaxel
D000068196	Albumin-Bound Paclitaxel

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal