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Combination chemotherapy with ONE of the following regimens:

* PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC (area under curve) 5 on day 1 every 4 weeks;
* GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days;
* PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days.

Combination chemotherapy AND bevacizumab with ONE of the following regimens:

* PLD-C: Pegylated liposomal doxorubicin 30 mg/m2 + Carboplatin AUC 5 on day 1 every 4 weeks and Bevacizumab 10 mg/kg i.v. on Day 1 every 2 weeks;
* GEM-C: Gemcitabine 1000 mg/m2 on day 1, 8 every 21 + Carboplatin AUC of 4 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks;L
* PAC-C: Paclitaxel 175 mg/m2 on day 1, every 21 + Carboplatin AUC of 5 on day 1 every 21 days AND Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks.

Patients whose disease has not progressed after the initial six cycles of combination treatment will continue bevacizumab, at 15 mg/kg every 3 weeks until disease progression,unacceptable toxicity or patient withdrawn.

pegylated liposomal doxorubicin

Sandro Pignata, M.D., Ph.D.

Nicoletta Colombo, M.D.

Francesco Perrone, M.D., Ph.D.

Gennaro Daniele, M.D., Ph.D.

Roldano Fossati, M.D.

Ciro Gallo, M.D.

Irene Floriani, Ph.D.

Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer

Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

according to Common Toxicity Criteria for Adverse Events v. 4.03

as measured by independent central review

Mario Negri Institute for Pharmacological Research

National Cancer Institute, Naples

* 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

• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles

• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles

• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles

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.

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.

Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab

A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer	NCT01802749	Recurrent Ovari...	Bevacizumab Paclitaxel Carboplatin pegylated lipos... Gemcitabine	18 Years -	National Cancer Institute, Naples
Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab	NCT01706120	Ovarian Cancer	Bevacizumab Paclitaxel Carboplatin	18 Years -	National Cancer Institute, Naples
Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer	NCT01802749	Recurrent Ovari...	Bevacizumab Paclitaxel Carboplatin pegylated lipos... Gemcitabine	18 Years -	National Cancer Institute, Naples

Spots Global Cancer Trial Database for biologic factors