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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

Phase 2
18 Years
Open (Enrolling)
Ovarian Sex-cord Stromal Tumor

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Trial Information

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

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

- Tumours within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence > 90 days following completion of radiotherapy.

- Patients must have been pre-treated with at least 1 prior line of platinum-based

- Adequate bone marrow, liver and renal functions including the following:

- 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 ≥9g/dL

- AST/ALT ≤ 3 x upper limit of normal (ULN) (or ≤ 5.0 ULN if liver metastasis) and
total bilirubin ≤ 1.5 ULN

- 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

- Adequate coagulation panel:

- PT ≤ 1.2 ULN

- aPTT ≤ 1.5 ULN

- INR ≤ 1.5 ULN

- 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

- Previous bilateral salpingo-oophorectomy or hysterectomy

- XY genotype, Turner's syndrome, or uterine agenesis

- Female patient who do not meet at least of the above criteria are defined
as women of childbearing potential

- 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

- 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:

- Myocardial infarction or instable angina within 6 months prior to first dose of
study drugs

- NYHA grade ≥ II congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Peripheral vascular disease ≥ grade 3

- 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:

- Major surgical procedure, open biopsy, or significant traumatic injury within 28
days prior to study inclusion or anticipation of need for major surgical
procedure during the course of the study

- Current or recent treatment with another investigational drug within 30 days of
first study treatment dosing or within 6 weeks in case of prior nitrozo-urea and
or mitomycin C treatment. In case of hormonotherapy , patients will be eligible
if hormonotherapy is discontinued within at least 1 week before treatment

- Current or recent (within 10 days prior to randomization) chronic use of
aspirin> 325 mg/day or use of any other inhibitor of platelet aggregation

- Chronic treatment (i.e. > 15 days) with non steroids anti-inflammatory agents
unless a washout period of 15 days was observed before the inclusion.

- Intake of granulocyte growth factor within 3 weeks before study entry

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical benefit of combining bevacizumab treatment to weekly paclitaxel

Outcome Description:

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

Outcome Time Frame:

after 6 months of treatment

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, LYON, FRANCE


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

February 2013

Completion Date:

January 2021

Related Keywords:

  • Ovarian Sex-cord Stromal Tumor
  • Sex Cord-Gonadal Stromal Tumors