REGorafenib vsTamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

NCT02584465 | Completed Phase 2 DMC

• 1 other identifier: GINECO-OV235
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 21

Brief Summary

The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

Conditions

Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free survival (PFS)

  PFS according to the RECIST 1.1 criteria, based on the investigator's assessment.

  4 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  4 months

• Time to start of first subsequent chemotherapy (TFST)

  5 months

• Second progression-Free Survival (PFS2)

  6 months

• Overall Survival (OS)

  7 months

• Adverse events

  7 months

Study Arms (2)

A-Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 40mg/day 2 film-coated tablet containing 20 mg of Tamoxifen/day until progression

Drug: Tamoxifen

B-Regorafenib

EXPERIMENTAL

Regorafenib 120mg/day 3 film-coated tablet containing 40 mg of Regorafenib/day, 3 weeks/4 until progression

Drug: Regorafenib

Interventions

Tamoxifen DRUG

Tamoxifen: 40 mg/day

A-Tamoxifen

Regorafenib DRUG

Stivarga; 120mg/day

B-Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I2 Histological confirmation of epithelial ovarian, fallopian tube, or primary peritoneal cancer, I3 Rising CA-125 (according to the Rustin/GCIG criteria, see appendix 10)) occurring more than 6 months after the last platinum-based chemotherapy cycle (platinum sensitive), I4 No symptom related to ovarian cancer progression, I6 1 or 2 prior lines of platinum-based chemotherapy followed either by surveillance or bevacizumab or olaparib (outside therapeutic trial) maintenance, I7 Before randomization, patients must be in CR, PR or SD (RECIST version 1.1) under surveillance or maintenance with bevacizumab or olaparib,
• I8 Adequate bone marrow, liver and renal functions as assessed by the following laboratory tests conducted within 7 days before randomization:
• Absolute Neutrophil Count ≥ 1.5 G/L, platelets count ≥ 100 G/L, and hemoglobin ≥ 9g/dL,
• AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) and total bilirubin ≤ 1.5 x ULN, Alkaline phosphatase ≤ 2.5 x ULN
• Serum creatinine ≤ 1.5 x ULN,
• Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m² according to the Modification of Diet Renal Disease (MDRD) abbreviated formula
• Lipase ≤ 1.5 x ULN
• Prothrombine time-international normalized ratio (PT-INR) \< 1.5 x ULN. Patients who are therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in this parameter exists, I9 Women of childbearing potential and partners must agree to use adequate contraceptive method (if no previous bilateral annexectomies) during the whole study period and for up to 6 months after the last dose of study treatment; a negative pregnancy test must be obtained prior to randomization,

You may not qualify if:

• E4 Past or concurrent history of neoplasm other than ovarian cancer, except for in situ carcinoma of the cervix uteri, in situ breast cancer and/or basal cell epithelioma. All treats and cures cancer more than 3 years before the study entry is allowed E5 Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system (CNS) disease if the patient has symptoms suggestive or consistent with progressive CNS disease), E6 Any prior radiotherapy to the pelvis or abdomen; surgery (including open biopsy) within 4 weeks before starting study drugs (24 hours for minor surgical procedures), or planned major surgery during the study treatment period, E7 Any prior treatment with anti angiogenic agent such as pazopanib, nintedanib or cediranib.
• E8 Endocrine therapy administered within 3 years prior to randomization,
• E13 History of any of the following :
• abdominal fistula,
• gastrointestinal perforation,
• intra-abdominal abscess,
• any malabsorption condition, E14 Clinically significant bleeding NCI-CTCAE version 4.3 Grade 3 or higher within 30 days before randomization, E15 Congestive heart failure New York Heart Association (NYHA) ≥ class 2, E17 Uncontrolled hypertension (systolic blood pressure (BP) \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management), E21 Ongoing infection \> Grade 2 according to NCI-CTCAE version 4.3. Hepatitis B is allowed if no active replication is present. Hepatitis C is allowed if no antiviral treatment is required, E23 Interstitial lung disease with ongoing signs and symptoms at the time of screening,

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Bayer: collaborator

Study Sites (21)

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Hospitalier de Cholet

Cholet, 49300, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Universitaire Dupuytren

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

Hôpital de Mont-de-Marsan

Mont-de-Marsan, 40024, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

ORACLE - Centre d'Oncologie de Gentilly

Nancy, 54100, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45067, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Clinique Francheville

Périgueux, 24004, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre CARIO - HPCA

Plérin, 22190, France

Location

Centre Hospitalier Annecy Genevois

Pringy, 74374, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

ICO Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Centre Hospitalier Universitaire Bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Tamoxifen; regorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Olivier Olivier, MD

  olivier.tredan@lyon.unicancer.fr

  PRINCIPAL INVESTIGATOR

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: July 29, 2015
• First Posted: October 22, 2015
• Study Start: August 28, 2015
• Primary Completion: September 19, 2021
• Study Completion: September 19, 2021
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

FR (21)