UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Open Label, Phase II Trial of Bevacizumab Plus Weekly Paclitaxel Followed by Bevacizumab Monotherapy Maintenance Versus Weekly Paclitaxel Followed by Observation in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
Title of the study (Brief title)	Efficacy and Safety of Bevacizumab (Avastin) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
Region	Japan Europe

Condition
Condition	Ovarian Sex-cord Stromal Tumor
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate clinical benefit of combining bevacizumab treatment to weekly paclitaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the clinical benefit of combining bevacizumab treatment to weekly paclitaxel measured by the non-progression rate after 6 months of treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Paclitaxel
Interventions/Control_2	Bevacizumab
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Female aged >=18 years at inclusion 2.Histologically confirmed diagnosis of ovarian Sex cord-stromal tumors including the following cell types: granulosa cell tumours (adults and juveniles types), granulosa cell-theca cell tumour, Sertoli-Leydig cell tumours, malignant steroid cell tumours, gynandroblastoma, unclassified SCST and mixed tumours 3.Documented relapse of SCST defined by progression of disease (radiologic, clinic or biological progression) 4.At least one measurable site of disease as defined by RECIST 1.1 5.Patients must have been pre-treated with at least 1 prior line of platinum-based chemotherapy 6.Adequate bone marrow, liver and renal functions including the following: 1)Absolute neutrophil count >=1.5 G/L, platelet count >=100 G/L, and hemoglobin >= 9 g/dL. Prior transfusion is authorized to keep haemoglobin level to >= 9 g/dL 2)AST/ALT <= 3 x upper limit of normal (ULN) (or <= 5.0 ULN if liver metastasis) and total bilirubin <= 1.5 ULN 3)Serum creatinine <= 1.5 ULN or calculated creatinine clearance >= 50 mL/min according to Cockcroft formula (or to MDRD formula for patients older than 65 years-old). 7.Adequate coagulation panel: 1)PT <=1.2 ULN 2)aPTT <= 1.5 ULN 3)INR <= 1.5 ULN 8.Adequate neurologic function: only neuropathy (sensory and motor) grade <= 1 (CTCAE v4.3) are allowed 9.ECOG Performance status of 0, 1, or 2 10.Life expectancy >= 4 months 11.Satisfactory cardiac function 12.Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry 13.Women of childbearing potential are required to have a negative serum pregnancy test within 7 days prior to study treatment initiation (i.e. Cycle 1 Day 1) and are willing to use adequate contraceptive method during the whole study period and for up to 6 months after the last treatment intake 14.Covered by a medical insurance (in country where applicable)
Key exclusion criteria	1.Prior systemic therapy with bevacizumab 2.Active peripheral neuropathy >= grade 3 (NCI-CTCAE v4.3) 3.Prior history of other malignancies other than ovarian SCST unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer 4.No resolution of specific toxicities related to any prior anti-cancer therapy to grade <=1, excluding alopecia, according to the NCI-CTCAE v.4.3 5.History or evidence of thrombotic or hemorrhagic disorders or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs 6.Uncontrolled arterial hypertension despite optimal antihypertensive therapy or clinically significant cardiovascular disease 7.History of bowel obstruction, including sub-occlusive syndrome and history of abdominal fistula, gastro-intestinal perforation or intra-abdominal abscess during the year prior to inclusion 8.Prior treatments: 1)Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study 2)Another investigational drug within 30 days of first study treatment dosing 3)Chronic use of aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation 4)Chronic treatment with non steroids anti-inflammatory agents 5)Intake of granulocyte growth factor within 3 weeks before study entry 9.Treatment during the study: 1)Debulking surgery prior to disease progression is not foreseen 2)Concurrent radiotherapy during the study treatment 10.Presence of hematuria and proteinuria >= 2+ (urine dipstick). 11.Untreated evolutive brain metastases 12.Active bacteria or fungal infection 13.Known HIV1, HIV2 or chronic hepatitis B or C infection 14.Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies 15.Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel or to any of the excipients
Target sample size	60

Research contact person
Name of lead principal investigator	Isabelle RAY-COQUARD
Organization	Centre Leon Berard, LYON, FRANCE
Division name	-
Address	Lyon, France, 69373
TEL	+33-4-78-78-28-28
Email	isabelle.ray-coquard@lyon.unicancer.fr

Public contact
Name of contact person	Keiichi Fujiwara, MD.,PhD
Organization	Saitama Medical University International Medical Center
Division name	Department of Gynecologic Oncology
Address	1397-1 Yamane, Hidaka-city, Saitama
TEL	+81-42-984-4111
Homepage URL
Email	fujiwara@saitama-med.ac.jp

Sponsor
Institute	ARCAGY/ GINECO GROUP
Institute
Department

Funding Source
Organization	GOTIC (Gynecologic Oncology Trial and Investigation Consortium of Kanto)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01770301
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	埼玉医科大学国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 06 Day
Anticipated trial start date	2015 Year 01 Month 07 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 06 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018738