Ovarian CancerPhase 2TAPAZNCT02383251
Paclitaxel/Pazopanib for Platinum Resistant/Refractory Ovarian Cancer
A Phase 2 study testing Pazopanib and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 36 sites in France.
Trial summary
Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Pazopanib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 36 sitesFrance
- Study dates
- 15 Jun 2015to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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:
Show all 28Show fewer
- 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:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
- Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- to 14: All risk of bleeding
- 15 Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. 16 Unable or unwilling to discontinue use of prohibited medications 17 Treatment with any of the following anti-cancer therapies:
- radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib (out of bevacizumab) OR
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib (out of bevacizumab) 18 Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment 19 Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. 20 Patient deprived of liberty or state-controlled 21 Inability to participate to medical follow up for geographic
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
Hôpital Henri Duffaut
Avignon, 84902
Institut Bergonié
Bordeaux, 33076
Polyclinique Bordeaux Nord
Bordeaux, 33300
Centre François Baclesse
Caen, 14000
Centre Jean Perrin
Clermont-Ferrand, 63000
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier de Dax
Dax, 40107
Centre Georges François Leclerc
Dijon, 21079
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38028
Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043
Hôpital André Mignot
Le Chesnay, 78157
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000
Centre Oscar Lambret
Lille, 59200
Hôpital de la Croix Rousse
Lyon, 69317
Centre Léon Bérard
Lyon, 69373
Hôpital Européen
Marseille, 13003
Institut Paoli Calmettes
Marseille, 13009
Hôpital de Mont-de-Marsan
Mont-de-Marsan, 40024
ICM Val d'Aurelle
Montpellier, 34298
ORACLE - Centre d'Oncologie de Gentilly
Nancy, 54100
Centre Catherine de Sienne
Nantes, 44202
Centre ONCOGARD - Institut de Cancérologie du Gard
Nîmes, 30029
Centre Hospitalier Régional d'Orléans
Orléans, 45067
Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin
Paris, 75014
Clinique Francheville
Périgueux, 20004
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
HPCA - Hôpital Privé des Côtes d'Armor
Plerin SUR MER, 22190
"Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie"
Poitiers, 86021
Institut du Cancer Courlancy Reims
Reims, 51100
ICO Centre René Gauducheau
Saint-Herblain, 44805
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Centre Paul Strauss
Strasbourg, 67065
Centre Hospitalier de Thonon-les-Bains
Thonon-les-Bains, 74203
Centre Hospitalier Universitaire Bretonneau
Tours, 37000
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
Gustave Roussy
Villejuif, 94805
About this study
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 of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.
Read the 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
- Conditions
- Ovarian Cancer
- Being tested
- Pazopanib, Paclitaxel
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Votrient
Pazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg
PaclitaxelDrug
Also called Taxol
Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib/Paclitaxel association | Experimental | Arm 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 Receives: Drug: Pazopanib; Drug: Paclitaxel |
| Paclitaxel alone | Active comparator | Arm 2 :
* Paclitaxel 80mg/m2 i.v. on days 1, 8, 15
* every 28 days until progression of disease or toxicity Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Proportion of progression or death 4 months after initiation of treatment
Measured: 4 months
Secondary outcomes (4)
Overall survival
Time between randomization and death or last news date for patient alive at the last visit date
Measured: Up to 2 years
Disease control rate (DCR)
Proportion of woman in partial, compete or stable desease according to RECIST 1.1. criteria
Measured: Up to 2 years
Toxicity according to NCI CTCAE v4.3 criteria
tolerance of the treatment based on AE occurrence according to NCI CTCAE v4.3 criteria
Measured: Up to 2 years
health-related quality of life
health-related quality of life and symptomatic state will be evaluated by filing questionnaires by patients
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start15 Jun 2015
- Primary completionAug 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Florence JOLY, PHD, Principal investigator, Centre François Baclesse, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383251
- Sponsor's protocol ID
- GINECO-OV231
- Acronym
- TAPAZ
- Status last verified
- Sep 2023
- First submitted
- 4 Mar 2015
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37185961Joly 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.
PubMed 35902297
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02383251
- Acronym / sponsor ID
- TAPAZ / GINECO-OV231
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pazopanib/Paclitaxel association | Experimental | Drug: Pazopanib, Drug: PaclitaxelArm 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 comparator | Drug: PaclitaxelArm 2 : * Paclitaxel 80mg/m2 i.v. on days 1, 8, 15 * every 28 days until progression of disease or toxicity |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibAlso: VotrientPazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg | Drug | Pazopanib/Paclitaxel association |
| PaclitaxelAlso: TaxolArm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m² | Drug | Paclitaxel alone, Pazopanib/Paclitaxel association |
Primary outcome
Progression free survival (PFS)
Time frame: 4 months
Proportion of progression or death 4 months after initiation of treatment
4 secondary outcomes
Overall survival
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Toxicity according to NCI CTCAE v4.3 criteria
Time frame: Up to 2 years
health-related quality of life
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 37185961Gaitskell 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.
- Derived from this study: PubMed 35902297Joly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence JOLY, PHD principal investigator
Centre François Baclesse, Caen
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib and Paclitaxel in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 36 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02383251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.