Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
Primary Purpose
Advanced Ovarian Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Ovarian Cancer focused on measuring advanced ovarian cancer, upfront treatment, bevacizumab
Eligibility Criteria
Inclusion Criteria:
- Female patients diagnosed with advanced ovarian cancer by biopsy
- Age more than 18 years old
- Routine labs are within normal values ( CBC, renal function tests , liver function tests )
- Performance score 0-2
- FIGO stage II-IV
- Not having any contraindication to bevacizumab as : uncontrolled hypertension , bleeding tendency , ischaemic events
- Chemotherapy naïve.
- Informed consent
Exclusion Criteria:
- patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis
- patients with uncontrolled infection
- patients with clinically significant cardiovascular disease
- patients with active bleeding or conditions associated with high risk of bleeding
- patients with history of CNS disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
advanced ovarian cancer cases
Arm Description
patients with advanced ovarian cancer will receive Bevacizumab 15 mg/kg every 21 days with chemotherapy (Paclitaxel 175 mg/m2 & Carboplatin AUC 5 every 21 days)
Outcomes
Primary Outcome Measures
progression free survival
determination of time from starting treatment until first progression
Secondary Outcome Measures
Full Information
NCT ID
NCT03611179
First Posted
July 17, 2018
Last Updated
July 26, 2018
Sponsor
Nada Hassan Salah
Collaborators
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03611179
Brief Title
Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
Official Title
Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nada Hassan Salah
Collaborators
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.
Detailed Description
Ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer death in women .The majority of women with ovarian cancer are diagnosed with advanced-stage disease; only 15% of all cases are diagnosed with local disease. Risk factors for ovarian cancer include family history, nulliparity, lack of breast feeding, and infertility .
The GOG-0218 trial demonstrated that the use of bevacizumab in the front-line and maintenance setting improved progression free survival by 3.8 months when compared with conventional every-3-weeks carboplatin and paclitaxel.
The ICON-7 trial also aimed to compare the progression free survival and Overall survival in women who receive bevacizumab with carboplatin/paclitaxel and women receiving carboplatin/paclitaxel alone The final results of ICON7 were announced in 2013. Overall, the results showed no difference in overall survival between those in the group receiving bevacizumab han those in the group receiving no bevacizumab. However, for high-risk patients, who were most likely to have early disease progression, the results were positive and showed an improvement in overall survival of 4.8 months in the group who received bevacizumab.
Not only has the best route been intensely debated but the optimal timing of therapy has been and is currently being studied. Chemotherapy is usually given either only after primary debulking surgery or as both neoadjuvant chemotherapy before and after interval debulking surgery. recent trials have tried to determine which treatment timing is associated with better outcomes .
The aim of the study will be assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Cancer
Keywords
advanced ovarian cancer, upfront treatment, bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
40 patients diagnosed with advanced epithelial ovarian cancer presenting to Assiut university hospitals ,,the aim of the study is evaluation of response, survival and toxicity of upfront chemotherapy with Bevacizumab in those patients.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
advanced ovarian cancer cases
Arm Type
Experimental
Arm Description
patients with advanced ovarian cancer will receive Bevacizumab 15 mg/kg every 21 days with chemotherapy (Paclitaxel 175 mg/m2 & Carboplatin AUC 5 every 21 days)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Chemotherapy drugs
Intervention Description
The chemotherapy regimen will be Paclitaxel (175 mg/m2 of body surface area) administered intravenously over 3 h, followed by carboplatin (area under the curve 5) over 1 h, with standard antiemetic and hypersensitivity medications.
In patients who develop dose-limiting peripheral neuropathy or hypersensitivity, paclitaxel will be replaced with docetaxel (75 mg/m2), which is administered intravenously over 1 h.
Bevacizumab (15 mg/kg bodyweight) administered intravenously initially over 90 min (if tolerated, this time can be reduced to 60 min, and could be further reduced to a minimum of 30 min)
Primary Outcome Measure Information:
Title
progression free survival
Description
determination of time from starting treatment until first progression
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females diagnosed with ovarian cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients diagnosed with advanced ovarian cancer by biopsy
Age more than 18 years old
Routine labs are within normal values ( CBC, renal function tests , liver function tests )
Performance score 0-2
FIGO stage II-IV
Not having any contraindication to bevacizumab as : uncontrolled hypertension , bleeding tendency , ischaemic events
Chemotherapy naïve.
Informed consent
Exclusion Criteria:
patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis
patients with uncontrolled infection
patients with clinically significant cardiovascular disease
patients with active bleeding or conditions associated with high risk of bleeding
patients with history of CNS disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nada H salah, ass.lect
Phone
01090779001
Ext
+2
Email
nada.h.salah88@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ola N abdel fattah, ass.prof
Phone
01023080090
Ext
+2
Email
olanabih1980@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed A mekkawy, prof
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohammed A hassan, lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
hisham abo taleb, lecturer
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26742998
Citation
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
Results Reference
background
PubMed Identifier
10188721
Citation
Aarnio M, Sankila R, Pukkala E, Salovaara R, Aaltonen LA, de la Chapelle A, Peltomaki P, Mecklin JP, Jarvinen HJ. Cancer risk in mutation carriers of DNA-mismatch-repair genes. Int J Cancer. 1999 Apr 12;81(2):214-8. doi: 10.1002/(sici)1097-0215(19990412)81:23.0.co;2-l.
Results Reference
background
PubMed Identifier
26240233
Citation
Wright AA, Cronin A, Milne DE, Bookman MA, Burger RA, Cohn DE, Cristea MC, Griggs JJ, Keating NL, Levenback CF, Mantia-Smaldone G, Matulonis UA, Meyer LA, Niland JC, Weeks JC, O'Malley DM. Use and Effectiveness of Intraperitoneal Chemotherapy for Treatment of Ovarian Cancer. J Clin Oncol. 2015 Sep 10;33(26):2841-7. doi: 10.1200/JCO.2015.61.4776. Epub 2015 Aug 3.
Results Reference
background
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Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
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