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Spots Global Cancer Trial Database for Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer

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Trial Identification

Brief Title: Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer

Official Title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance

Study ID: NCT02383251

Conditions

Ovarian Cancer

Interventions

Pazopanib
Paclitaxel

Study Description

Brief Summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.

Detailed Description: Standard of treatments: * In Europe, advanced ovarian cancer patients are treated in first line with optimal debulking surgery followed by carboplatin/paclitaxel regimen plus bevacizumab during chemotherapy and as maintenance for a total à 15 months. The addition of bevacizumab is a standard for the patients with residual disease. * The addition of bevacizumab to carboplatin/gemcitabine chemotherapy was also recently approved for patients with platinum sensible relapse \[Aghajanian, 2012\]. The bevacizumab is maintained until progression. Rationale to use anti-angiogenic agents in early relapse: * The recent AURELIA trial comparing paclitaxel, topotecan or liposomal doxorubicin alone versus combined to bevacizumab after early failure of the first-line with carboplatin/paclitaxel revealed that targeting angiogenesis was beneficial in recurrent platinum-resistant ovarian cancer \[Pujade-Lauraine, 2012 and 2013\], with higher progression-free survival (PFS). Thus, the strategy of inhibiting angiogenesis in recurrent resistant-platinum ovarian cancer is very promising. * The recent changes of the standard of treatment of first line and platinum-sensible relapse of patients with ovarian cancer highlights the question of inhibiting angiogenesis for relapse during/after bevacizumab maintenance. In this last situation, the strategy of continuation of antiangiogenesis therapy, just in changing chemotherapy despite recurrence, showed benefit in other types of cancer (colon, lung). In ovarian cancer, no study has been performed to answer to the question. In Aurelia trial, However, patients did not previously receive bevacizumab. The choice of the best antiangiogenic agent in alternative to bevacizumab needs to be assessed. Small molecular inhibitor of tyrosine-protein-kinases (TK) could be used with efficacy after a first-line of antiangiogenesis treatment as it was demonstrated in renal cancer \[Escudier, 2011\]. * Pazopanib is an oral, potent multi-targeted small-molecule inhibitor of VEGF-receptor TKs (VEGFR-1 -2 -3 PDGFR and c-KIT; it is the first targeted small molecule that it has demonstrated an important activity in ovarian cancer. At ASCO 2013, the AGO-OVAR16 trial of maintenance of pazopanib in first line ovarian cancer has shown a benefit in progression free survival (difference of 5.6 months of median PFS in favour of pazopanib compared to placebo) \[Dubois, ASCO 2013 LBA5503\]; in this trial, the majority of the patients had few residual disease and patients did not receive bevacizumab. * In ovarian cancer, the standard treatment for patients relapsing during bevacizumab maintenance (15 to 20% of patients) is still a mono-chemotherapy. Weekly paclitaxel is one oh the most commonly used chemotherapy in this situation of early relapse. However, the promising results of pazopanib in first line led to develop protocols in second-line in combination with chemotherapy. The combination of weekly paclitaxel and pazopanib is feasible and the dose proposed for further phase 2 studies is pazopanib 800 mg daily and paclitaxel 65 mg/m2 at day 1, 8, 15 every 28 days \[Tan, the oncologist 2010\]. The dosage of paclitaxel was justified on results from previous studies, demonstrating that co-administration of pazopanib and paclitaxel increases the systemic exposure to paclitaxel. An Italian group has just closed a phase 2 study (MITO11) that evaluated this association among ovarian patients with early relapse. In this study, patients did not receive previously bevacizumab. Thus, pazopanib is the best molecule to be associated to chemotherapy in ovarian cancer patients who early relapse after a treatment including bevacizumab. We propose a randomized phase 2 trial to evaluate the combination of pazopanib to weekly paclitaxel among patients with platine resistant relapse after treatment including bevacizumab maintenance

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Hôpital Henri Duffaut, Avignon, , France

Institut Bergonié, Bordeaux, , France

Polyclinique Bordeaux Nord, Bordeaux, , France

Centre François Baclesse, Caen, , France

Centre Jean Perrin, Clermont-ferrand, , France

Centre Hospitalier Intercommunal de Créteil, Creteil, , France

Centre Hospitalier de Dax, Dax, , France

Centre Georges François Leclerc, Dijon, , France

Groupe Hospitalier Mutualiste de Grenoble, Grenoble, , France

Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble, Grenoble, , France

Hôpital André Mignot, Le Chesnay, , France

Centre Jean Bernard - Clinique Victor Hugo, Le Mans, , France

Centre Oscar Lambret, Lille, , France

Hôpital de la Croix Rousse, Lyon, , France

Centre Léon Bérard, Lyon, , France

Hôpital Européen, Marseille, , France

Institut Paoli Calmettes, Marseille, , France

Hôpital de Mont-de-Marsan, Mont-de-marsan, , France

ICM Val d'Aurelle, Montpellier, , France

ORACLE - Centre d'Oncologie de Gentilly, Nancy, , France

Centre Catherine de Sienne, Nantes, , France

Centre ONCOGARD - Institut de Cancérologie du Gard, Nimes, , France

Centre Hospitalier Régional d'Orléans, Orléans, , France

Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin, Paris, , France

Clinique Francheville, Perigueux, , France

Centre Hospitalier Lyon Sud, Pierre Benite, , France

HPCA - Hôpital Privé des Côtes d'Armor, Plerin SUR MER, , France

"Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie", Poitiers, , France

Institut du Cancer Courlancy Reims, Reims, , France

ICO Centre René Gauducheau, Saint-herblain, , France

Hôpitaux Universitaires de Strasbourg, Strasbourg, , France

Centre Paul Strauss, Strasbourg, , France

Centre Hospitalier de Thonon-les-Bains, Thonon-les-Bains, , France

Centre Hospitalier Universitaire Bretonneau, Tours, , France

ICL Institut de Cancérologie de Lorraine, Vandoeuvre-les-nancy, , France

Gustave Roussy, Villejuif, , France

Contact Details

Name: Florence JOLY, PHD

Affiliation: Centre François Baclesse, Caen

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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