Unique ID issued by UMIN | UMIN000016138 |
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Receipt number | R000018738 |
Scientific Title | 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 |
Date of disclosure of the study information | 2015/01/07 |
Last modified on | 2019/02/25 13:00:41 |
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
Efficacy and Safety of Bevacizumab (Avastin) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
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
Efficacy and Safety of Bevacizumab (Avastin) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours
Japan | Europe |
Ovarian Sex-cord Stromal Tumor
Obstetrics and Gynecology |
Malignancy
YES
To evaluate clinical benefit of combining bevacizumab treatment to weekly paclitaxel.
Safety,Efficacy
To evaluate the clinical benefit of combining bevacizumab treatment to weekly paclitaxel measured by the non-progression rate after 6 months of treatment.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Paclitaxel
Bevacizumab
18 | years-old | <= |
Not applicable |
Female
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)
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
60
1st name | |
Middle name | |
Last name | Isabelle RAY-COQUARD |
Centre Leon Berard, LYON, FRANCE
-
Lyon, France, 69373
+33-4-78-78-28-28
isabelle.ray-coquard@lyon.unicancer.fr
1st name | |
Middle name | |
Last name | Keiichi Fujiwara, MD.,PhD |
Saitama Medical University International Medical Center
Department of Gynecologic Oncology
1397-1 Yamane, Hidaka-city, Saitama
+81-42-984-4111
fujiwara@saitama-med.ac.jp
ARCAGY/ GINECO GROUP
GOTIC (Gynecologic Oncology Trial and Investigation Consortium of Kanto)
Non profit foundation
YES
NCT01770301
ClinicalTrials.gov
埼玉医科大学国際医療センター(埼玉県)
2015 | Year | 01 | Month | 07 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 06 | Day |
2015 | Year | 01 | Month | 07 | Day |
2019 | Year | 03 | Month | 31 | Day |
2015 | Year | 01 | Month | 06 | Day |
2019 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018738
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