Clinical trial NCT03611179: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Ovarian Cancer
Keywords: advanced ovarian cancer
upfront treatment
bevacizumab
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2018-08-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: mohammed A mekkawy, prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mohammed A hassan, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: hisham abo taleb, lecturer
role: STUDY_DIRECTOR
References:
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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.