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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Interventions: Drug: carboplatin
Drug: Bevacizumab
Drug: Paclitaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from January to December 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with a histologically or cytologically confirmed EOC with radiographic evidence of advanced disease, consistent with FIGO stage IIIC or IV.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Carboplatin + Weekly Paclitaxel and Bevacizumab
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5  55.6% 
>=65 years      4  44.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      9 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      9 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Patients]
 
United States   9 


  Outcome Measures

1.  Primary:   Tolerated Dose   [ Time Frame: Up to 6 months ]

2.  Secondary:   Toxicity and Response Rates Based on Imaging and Surgical Outcomes   [ Time Frame: Up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ritu Salani, MD, MBA
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-3873
e-mail: Ritu.Salani@osumc.edu



Responsible Party: Ritu Salani, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01219777     History of Changes
Other Study ID Numbers: OSU-09149
NCI-2012-00512 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Submitted: October 11, 2010
First Posted: October 13, 2010
Results First Submitted: May 6, 2015
Results First Posted: June 29, 2015
Last Update Posted: February 8, 2018