Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer
TAPAZ
A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance
1 other identifier
interventional
118
1 country
36
Brief Summary
Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Jun 2015
Typical duration for phase_2 ovarian-cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedStudy Start
First participant enrolled
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 6, 2023
September 1, 2023
4.1 years
March 4, 2015
September 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Proportion of progression or death 4 months after initiation of treatment
4 months
Secondary Outcomes (4)
Overall survival
Up to 2 years
Disease control rate (DCR)
Up to 2 years
Toxicity according to NCI CTCAE v4.3 criteria
Up to 2 years
health-related quality of life
Up to 2 years
Study Arms (2)
Pazopanib/Paclitaxel association
EXPERIMENTALArm 1 : Pazopanib alone during 1 week at 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal. Then: * Pazopanib 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal. * Paclitaxel 65 mg/m2 i.v. on days 1, 8, 15 every 28 days until progression of disease or toxicity
Paclitaxel alone
ACTIVE COMPARATORArm 2 : * Paclitaxel 80mg/m2 i.v. on days 1, 8, 15 * every 28 days until progression of disease or toxicity
Interventions
Pazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg
Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Performance status ECOG \< 2
- Histological documented ovarian, tubal or peritoneum carcinoma (stage IC to IV)
- Patient treated at least with one line of platinum-based chemotherapy who have relapsed within 6 months after trhe last administration of platinum-based chemotherapy and taking bevacizumab for maintenance NB: Penultimate line of chemotherapy could contain chemotherapy without platinum and the last line should contain platinum-based chemotherapy (followed by bevacizumab for maintenance)
- Patients must have disease that is measurable and/or evaluable according to RECIST criteria and requires chemotherapy treatment
- Patients with liver metastasis can be included
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Life expectancy of more than 3 months
- Able to swallow and retain oral medication
- Adequate organ system function like:
- Total bilirubin ≤ 1.5 X ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST)c ≤ 2.5 X ULN
- Subjects may not have had a transfusion within 7 days of screening assessment.
- Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
- Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permitted.
- If UPC \<1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value \<1 g to be eligible. Use of urine dipstick for renal function assessment is not acceptable. 10. Women of childbearing potential must agree to use effective contraception 11. Negative serum pregnancy test (if applicable) 12. Affiliated to or a beneficiary of a social security category
You may not qualify if:
- Prior malignancy over the past 5 years with the exception of in situ carcinomas of the cervix or basal and squamous cell carcinoma or nonmelanoma skin cancer properly treated, or all solid tumor, considered as in completed remission without relapse for at least 5 years
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants of P3A4 cytochrom
- Previous treatment with monotherapy weekly paclitaxel
- Previous treatment with bevacizumab within three weeks before start of studt treatment
- Patients with severe hypersensitivity to a product containing castor oil polyoxyl 35 or paclitaxel solvent: the Chremophor
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel.
- Corrected QT interval (QTc) \> 450 msecs or \> 480 msecs for patient with block branch
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARCAGY/ GINECO GROUPlead
- Novartiscollaborator
Study Sites (36)
Hôpital Henri Duffaut
Avignon, 84902, France
Institut Bergonié
Bordeaux, 33076, France
Polyclinique Bordeaux Nord
Bordeaux, 33300, France
Centre François Baclesse
Caen, 14000, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Hospitalier de Dax
Dax, 40107, France
Centre Georges François Leclerc
Dijon, 21079, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028, France
Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043, France
Hôpital André Mignot
Le Chesnay, 78157, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000, France
Centre Oscar Lambret
Lille, 59200, France
Hôpital de la Croix Rousse
Lyon, 69317, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital Européen
Marseille, 13003, France
Institut Paoli Calmettes
Marseille, 13009, France
Hôpital de Mont-de-Marsan
Mont-de-Marsan, 40024, France
ICM Val d'Aurelle
Montpellier, 34298, France
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54100, France
Centre Catherine de Sienne
Nantes, 44202, France
Centre ONCOGARD - Institut de Cancérologie du Gard
Nîmes, 30029, France
Centre Hospitalier Régional d'Orléans
Orléans, 45067, France
Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin
Paris, 75014, France
Clinique Francheville
Périgueux, 20004, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
HPCA - Hôpital Privé des Côtes d'Armor
Plerin SUR MER, 22190, France
"Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie"
Poitiers, 86021, France
Institut du Cancer Courlancy Reims
Reims, 51100, France
ICO Centre René Gauducheau
Saint-Herblain, 44805, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000, France
Centre Paul Strauss
Strasbourg, 67065, France
Centre Hospitalier de Thonon-les-Bains
Thonon-les-Bains, 74203, France
Centre Hospitalier Universitaire Bretonneau
Tours, 37000, France
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511, France
Gustave Roussy
Villejuif, 94805, France
Related Publications (2)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PMID: 37185961DERIVEDJoly F, Fabbro M, Berton D, Lequesne J, Anota A, Puszkiel A, Floquet A, Vegas H, Bourgeois H, Bengrine Lefevre L, You B, Pommeret F, Lortholary A, Spaeth D, Hardy-Bessard AC, Abdeddaim C, Kaminsky-Forrett MC, Tod M, Kurtz JE, Del Piano F, Meunier J, Raban N, Alexandre J, Mouret-Reynier MA, Ray-Coquard I, Provansal Gross M, Brachet PE. Paclitaxel with or without pazopanib for ovarian cancer relapsing during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study. Gynecol Oncol. 2022 Sep;166(3):389-396. doi: 10.1016/j.ygyno.2022.06.022. Epub 2022 Jul 26.
PMID: 35902297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence JOLY, PHD
Centre François Baclesse, Caen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 9, 2015
Study Start
June 15, 2015
Primary Completion
August 1, 2019
Study Completion
December 31, 2020
Last Updated
September 6, 2023
Record last verified: 2023-09