A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS
Overview
- Phase
- Phase 4
- Intervention
- Bevacizumab
- Conditions
- Ovarian Cancer
- Sponsor
- National Cancer Institute, Naples
- Enrollment
- 400
- Locations
- 47
- Primary Endpoint
- expression of soluble and tissutal biomarkers
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.
Detailed Description
MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as first line treatment (in-label dose and scheduling). This is an exploratory study attempting to identify potential prognostic clinical factors(such as hypertension) and prognostic biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those expressing the changing nature of the disease in relation to the treatment or simply the tumour progression, these are typically not inherited. Genetic biomarkers are typically inherited and are expression of some characteristics potentially able to interfere with the treatment effect (i.e. Pharmacogenomics). The safety of this regimen in routine clinical practice will also be described.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patients ≥18 years of age.
- •Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone.
- •FIGO stage IIIB \& C or IV
- •ECOG Performance Status of 0-
- •Life expectancy of at least 12 weeks.
- •Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
- •Availability of tumour samples for molecular analyses
Exclusion Criteria
- •Cancer related
- •Ovarian tumours with low malignant potential (i.e. borderline tumours)
- •Previous systemic anti-cancer therapy for advanced ovarian cancer.
- •History or evidence of brain metastases or spinal cord compression.
- •History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
- •stage ≤Ia
- •no more than superficial myometrial invasion
- •no lymphovascular invasion
- •not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
- •Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
Arms & Interventions
First-line chemotherapy with bevacizumab
* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Intervention: Bevacizumab
First-line chemotherapy with bevacizumab
* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Intervention: Paclitaxel
First-line chemotherapy with bevacizumab
* Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles * Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles * Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Intervention: Carboplatin
Outcomes
Primary Outcomes
expression of soluble and tissutal biomarkers
Time Frame: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient
Secondary Outcomes
- overall survival(three years)
- number of patients taking oral antidiabetic therapy(at baseline)
- progression free survival(one year)
- number of patients taking antithrombotic therapy(at baseline)
- worst grade toxicity per patient(evaluated every 3 weeks up to 15 month)