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About
Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called "angiogenesis"). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing.
In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers.
The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended.
This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized.
The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Female aged ≥ 18 years at inclusion
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
Documented relapse of SCST defined by progression of disease (radiologic, clinic or biological progression)
At least one measurable site of disease as defined by RECIST 1.1
Patients must have been pre-treated with at least 1 prior line of platinum-based chemotherapy
Adequate bone marrow, liver and renal functions including the following:
Adequate coagulation panel:
Adequate neurologic function: only neuropathy (sensory and motor) grade ≤ 1 (CTCAE v4.3) are allowed
ECOG Performance status of 0, 1, or 2 (Appendix 5)
Life expectancy ≥ 4 months
Satisfactory cardiac function
Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry
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
*: Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
≥ 50 years old and naturally amenorrheic for ≥ 1 year
Permanent premature ovarian failure confirmed by a specialist gynaecologist
Covered by a medical insurance (in country where applicable)
Exclusion criteria
Prior systemic therapy with bevacizumab
Active peripheral neuropathy ≥ grade 3 (NCI-CTCAE v4.3)
Prior history of other malignancies other than ovarian SCST (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years or 5 years for breast cancer
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
History or evidence of thrombotic or hemorrhagic disorders, including cerebro-vascular accident/stroke or transient ischemic attack or sub-arachnoids' haemorrhage within 6 months prior to first dose of study drugs
Uncontrolled arterial hypertension (systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg) despite optimal antihypertensive therapy or clinically significant cardiovascular disease including one of the following:
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
Prior treatments:
Presence of hematuria and proteinuria ≥ 2+ (urine dipstick). Patients with ≥ 2+ proteinuria on dipstick at screening should undergo a 24-hour urine collection and will be eligible only if 24-h proteinuria ≤ 1 g
Untreated evolutive brain metastases
Active bacteria or fungal infection (grade ≥2, CTC AE V4.3)
Known HIV1, HIV2 or chronic hepatitis B or C infection
Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies
Any contraindications to paclitaxel treatment: for example severe hypersensitivity reactions to paclitaxel, macrogolglycerol ricinoleate (polyoxyl castor oil) or to any of the excipients (Ethanol Citric acid) (refer to Taxol® SPC for further details)
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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