Upfront Treatment With Chemotherapy and Bevacizumab in Advanced Ovarian Cancer

Sponsor
Nada Hassan Salah
Study ID
NCT03611179
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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)

Study Details

Our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.

Key Dates

First listed
Aug 2, 2018
Start date
Sep 1, 2018
Status verified
Jul 2018
Primary completion
Aug 31, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

progression free survival [ Time Frame: 2 years ]

Central Contacts

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