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
- Conditions
- Ovarian Sex-cord Stromal Tumor
- Registration Number
- JPRN-UMIN000016138
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the clinical benefit of combining bevacizumab treatment to weekly paclitaxel measured by the non-progression rate after 6 months of treatment.
- Secondary Outcome Measures
Name Time Method