Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Recurrence

Disease Progression

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Paclitaxel

Carboplatin

Gemcitabine

Bevacizumab

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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will continue bevacizumab, at 15 mg/kg every 3 weeks until disease progression,unacceptable toxicity or patient withdrawn.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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer	NCT01802749	Recurrent Ovari...	Bevacizumab Paclitaxel Carboplatin pegylated lipos... Gemcitabine	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 first line bevacizumab