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Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03611179
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Assiut University
Information provided by (Responsible Party):
Nada Hassan Salah, Assiut University

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.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Cancer Drug: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: advanced ovarian cancer cases
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

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)

Other Name: Chemotherapy drugs

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 years ]
    determination of time from starting treatment until first progression

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females diagnosed with ovarian cancer
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03611179

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Contact: nada H salah, ass.lect 01090779001 ext +2
Contact: ola N abdel fattah, 01023080090 ext +2

Sponsors and Collaborators
Nada Hassan Salah
Assiut University
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Study Director: mohammed A mekkawy, prof Assiut University
Study Director: mohammed A hassan, lecturer Assiut University
Study Director: hisham abo taleb, lecturer Assiut University
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Responsible Party: Nada Hassan Salah, principal investigator, Assiut University Identifier: NCT03611179    
Other Study ID Numbers: bevacizumab in ovarian cancer
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nada Hassan Salah, Assiut University:
advanced ovarian cancer
upfront treatment
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors