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Ovarian Sex-cord Stromal TumorPhase 2ALIENORNCT01770301

Efficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR)

A Phase 2 study testing Paclitaxel and Bevacizumab in people with Ovarian Sex-cord Stromal Tumor, run by ARCAGY/ GINECO GROUP at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Sex-cord Stromal Tumor
What is being tested?
Paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
24 sitesFrance
Study dates
Feb 2013to Apr 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 chemotherapy
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  • 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 years-old).
  • 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)

Who cannot join

  • 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:
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  • 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 initiation
  • 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)

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • Hôpital Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord

    Bordeaux

  • Centre François Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • ICM Val d'Aurelle

    Montpellier, 34298

  • ORACLE - Centre d'Oncologie de Gentilly

    Nancy, 54100

  • Hôpital Privé du Confluent

    Nantes, 44202

  • Hôpital Cochin

    Paris, 75014

  • Groupe Hospitalier Diaconesses - Croix Saint-Simon

    Paris, 75020

  • Hôpital Tenon

    Paris, 75020

  • Centre CARIO - HPCA

    Plérin, 22190

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Henri Becquerel

    Rouen, 76038

  • ICO Centre René Gauducheau

    Saint-Herblain, 44800

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67200

  • Institut Claudius Regaud

    Toulouse, 31059

  • ICL Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54511

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official 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

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.

Read more

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

Being tested
Paclitaxel, Bevacizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01770301
Study groupRoleWhat they receive
A - PaclitaxelActive comparatorpatients will receive paclitaxel alone at the dose 80 mg/m² administered by intravenous injection at D1, D8 and D15 every 4 weeks for 6 cycles. Thereafter, patients will be followed-up with imaging exams every 12 weeks. At the time of confirmed progression, patients could receive bevacizumab 15 mg/kg every 3 weeks for 12 months following investigator's decision. In some cases, longer therapy may be allowed after discussion with the Principal Investigator/Sponsor
Receives: Drug: Paclitaxel
B - Paclitaxel + Bevacizumab followed by BevacizumabExperimentalpatients will receive paclitaxel at the dose 80 mg/m² administered by intravenous injection at D1, D8 and D15 every 4 weeks + Bevacizumab at the dose 10 mg/kg administered by intravenous injection every 2 weeks (D1 and D15) for 6 cycles. Thereafter, patients will receive IV injection of bevacizumab 15 mg/kg every 3 weeks for up to 1 year
Receives: Drug: Paclitaxel; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical benefit of combining bevacizumab treatment to weekly paclitaxel

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

    Measured: after 6 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2017
  4. Study completionApr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01770301
Sponsor's protocol ID
ALIENOR (GINECO-OV222)
Acronym
ALIENOR
Status last verified
Jun 2021
First submitted
15 Jan 2013
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Ray-Coquard I, Harter P, Lorusso D, Dalban C, Vergote I, Fujiwara K, Gladieff L, Luck HJ, Floquet A, Chevalier-Place A, Schnelzer A, Pignata S, Selle F, Sehouli J, Brocard F, Mangili G, Pautier P, De Giorgi U, Provansal M, Heudel PE. Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial. JAMA Oncol. 2020 Dec 1;6(12):1923-1930. doi: 10.1001/jamaoncol.2020.4574.

    PubMed 33030515

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Bevacizumab in people with Ovarian Sex-cord Stromal Tumor, run by ARCAGY/ GINECO GROUP at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical benefit of combining bevacizumab treatment to weekly paclitaxel (time frame: after 6 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01770301, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.

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