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Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer

Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum

NCT01583322•ARCAGY/ GINECO GROUP

View on ClinicalTrials.gov

Summary

Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin \& paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•First diagnosis of histological confirmed (cytology alone excluded) epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. Histology should be obtained by laparoscopy (or by laparotomy),
•FIGO-Stages IIIC - IV,
•ECOG performance status \< 2,
•Life expectancy of at least 6 months,
•Primary debulking surgery denied and maximum surgical effort of cytoreduction with the goal of no residual disease planned as interval debulking surgery,
•Interval between diagnosis and enrolment (informed consent) ≤ 8 weeks,
•Adequate hepatic, renal and bone marrow functions:
•Platelets \> 100 000 /μL, Hemoglobin \> 9.0 g/dL, Absolute Neutrophil Count (ANC) \> 1500/μL, Prothrombin time and/or partial thromboplastin time \< 50% deviation from normal limits in the absence of therapeutic anticoagulation, Proteinuria \< CTCAE grade 2, Total bilirubin ≤ upper limit of normal (ULN), ALT and/or AST ≤ 2.5 x ULN, Glomerular filtration rate \>40 mL/min,
•Females, age 18 years or older,
•Patient has given written informed consent,

Exclusion Criteria

•Histological diagnosis of malignant tumour of non-epithelial origin (e.g. germ cell tumour, malignant mixed mullerian tumour, sex cord-stromal tumour) of the ovary, the fallopian tube or peritoneum or borderline tumour of the ovary (tumour of low malignant potential),
•Non-healing wound, ulcer (intestinal tract, skin) or bone fracture,
•Clinical symptoms or signs of gastrointestinal obstruction,
•History of major thromboembolic event, defined as:
•* Pulmonary embolism (PE) within 6 months prior to enrolment,
•* Recurrent pulmonary embolism (history of at least 2 events),
•History of at least 2 unprovoked (without a transient or reversible risk factor) events of proximal deep venous thrombosis,
•Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy (including deficiency of antithrombin, deficiency of protein C or protein S, Factor V Leiden mutation, Prothrombin G20210A mutation),
•Patients with perioperative thrombosis including proximal deep vein thrombosis (DVT) or thrombosis of visceral vessels not associated with pulmonary embolism may be included in the trial if stable therapeutic anticoagulation is documented,
•Known inherited or acquired bleeding disorder,
+32 more criteria

Locations (36)

Centre Paul Papin

Angers, France

Institut Ste Catherine

Avignon, France

Clinique Tivoli

Bordeaux, France

Institut Bergonié

Bordeaux, France

Polyclinique Bordeaux Nord

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier Alpes Leman

Contamine-sur-Arve, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre Hospitalier de Dax

Dax, France

Key Dates

Start Date

June 1, 2012

Primary Completion Date

May 1, 2015

Completion Date

March 1, 2016

Last Updated

September 6, 2023

Enrollment

188

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

vargatef

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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