NCT03611179

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2018

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

July 17, 2018

Last Update Submit

July 26, 2018

Conditions

Advanced Ovarian Cancer

Keywords

advanced ovarian cancerupfront treatmentbevacizumab

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    determination of time from starting treatment until first progression

    2 years

Study Arms (1)

advanced ovarian cancer cases

EXPERIMENTAL

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)

Drug: Bevacizumab

Interventions

BevacizumabDRUG

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)

Also known as: Chemotherapy drugs
advanced ovarian cancer cases

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales diagnosed with ovarian cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26742998BACKGROUND

  • 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.

    PMID: 10188721BACKGROUND

  • 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.

    PMID: 26240233BACKGROUND

MeSH Terms

Interventions

BevacizumabAntineoplastic Agents

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • mohammed A mekkawy, prof

    Assiut University

    STUDY DIRECTOR

  • mohammed A hassan, lecturer

    Assiut University

    STUDY DIRECTOR

  • hisham abo taleb, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

nada H salah, ass.lect

CONTACT

01090779001nada.h.salah88@gmail.com

ola N abdel fattah, ass.prof

CONTACT

01023080090olanabih1980@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 2, 2018

Study Start

September 1, 2018

Primary Completion

August 31, 2022

Study Completion

September 1, 2022

Last Updated

August 2, 2018

Record last verified: 2018-07