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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
Nada Hassan Salah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Cancer focused on measuring advanced ovarian cancer, upfront treatment, bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 17, 2018
    Last Updated
    July 26, 2018
    Sponsor
    Nada Hassan Salah
    Collaborators
    Assiut University
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    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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