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Ovarian CancerPhase 2ANTHALYANCT01739218

A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable

A Phase 2 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Ovarian Cancer, run by Hoffmann-La Roche at 15 sites in France.

Completed

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

Official record
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Trial summary

This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Carboplatin, Paclitaxel and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
15 sitesFrance
Study dates
1 Feb 2013to 17 Aug 2016
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

  • Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
  • Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Life expectancy greater than or equal to (>/=) 3 months
  • Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards
  • Beneficiaries of healthcare coverage under the social security system

Who cannot join

  • Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma
  • Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Previous systemic therapy for ovarian cancer
  • Previous exposure to mouse CA-125 antibody
  • Current or recent (within 28 days prior to Day 1 of Cycle 1) treatment with another investigational drug or previous participation in this study
  • Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin greater than (>) 325 milligrams (mg) per day
Show all 15Show fewer
  • Planned intraperitoneal cytotoxic chemotherapy
  • Inadequate bone marrow, liver, or renal function
  • History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1
  • Uncontrolled hypertension
  • Clinically significant (active) cardiovascular disease such as New York Heart Association (NYHA) Class II or greater congestive heart failure, or aortic aneurism
  • Pre-existing peripheral neuropathy that is Common Toxicity Criteria (CTC) Grade >/=2
  • Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies, or to any planned chemotherapy
  • Pregnant or lactating females
  • History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • Chu D'Amiens

    Amiens, 80054

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Institut Bergonie; Oncologie

    Bordeaux, 33076

  • Centre Francois Baclesse; Chir Gynecologique

    Caen, 14076

  • Centre Jean Perrin; Chir Generale Oncologie

    Clermont-Ferrand, 63011

  • Centre Oscar Lambret; Cancerologie Gynecologique

    Lille, 59020

  • Institut J Paoli I Calmettes; Chir II

    Marseille, 13273

  • Centre Val Aurelle Paul Lamarque; Chir A1

    Montpellier, 34298

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • Institut Curie; Chir Generale Gyneco Oncologique

    Paris, 75231

  • Hop Europeen Georges Pompidou; Gynecologie

    Paris, 75908

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Centre Rene Huguenin; Chir Generale Oncologique

    Saint-Cloud, 92210

  • Hopital Rangueil; CHIR Generale Et Gynecologique

    Toulouse, 31059

  • Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn

    Villejuif, 94805

Other trials in France

About this study

Official title: A Randomized, Open-Label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable

This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery [IDS]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.

Conditions
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • CarboplatinDrug

    Carboplatin will be administered at a dose calculated according to the Calvert formula ([participant's glomerular filtration rate + 25] multiplied by the target area under the concentration-time curve [AUC] of 5 milligrams per milliliter per minute [mg/mL/min]), as intravenous [IV] infusion over 30-60 minutes [min] every 3 weeks).

  • PaclitaxelDrug

    Paclitaxel will be administered at a dose of 175 milligrams per meter-squared [mg/m^2] as IV infusion over 3 hours using a rate controlling device every 3 weeks, or at a dose of 80 mg/m^2 as IV infusion over 1 hour using a rate controlling device every week (only during Cycles 5 to 8).

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered at a dose of 15 milligrams per kilogram [mg/kg] as IV infusion over 30-90 min every 3 weeks.

Study groups in NCT01739218
Study groupRoleWhat they receive
Carboplatin + Paclitaxel + BevacizumabExperimentalParticipants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered during both the neoadjuvant and the adjuvant treatment periods in Cycles 1 to 26 (no treatment in Cycles 4 and 5).
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab
Carboplatin + PaclitaxelActive comparatorParticipants will receive 4 cycles of neoadjuvant therapy prior to IDS and 22 cycles of adjuvant therapy before entering long-term follow-up. Each cycle will be 3 weeks in length. Carboplatin and paclitaxel will be administered during Cycles 1 to 8. Bevacizumab will be administered only during the adjuvant treatment period in Cycles 6 to 26.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

What is being measured

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

  1. Percentage of Participants with Complete Resection After IDS

    Measured: After IDS (approximately 4 months from randomization)

  2. Percentage of Participants with Different CC Scores After IDS

    Measured: After IDS (approximately 4 months from randomization)

Secondary outcomes (8)

  1. Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)

  2. Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels

    Measured: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)

  3. Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response

    Measured: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)

  4. Percentage of Participants with RECIST v1.1 Objective Response Without CA-125 Response

    Measured: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)

  5. Percentage of Participants with CA-125 Response Without RECIST v1.1 Objective Response

    Measured: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)

  6. Number of Participants with Disease Progression or Death From any Cause

    Measured: From Baseline to disease progression or death due to any cause (up to approximately 38 months)

  7. Progression-Free Survival (PFS) According to RECIST v1.1

    Measured: From Baseline to disease progression or death due to any cause (up to approximately 38 months)

  8. Percentage of Participants with Serious Adverse Events (SAEs) and Non-SAEs

    Measured: SAEs: from randomization up to last assessment (up to approximately 38 months); non-SAEs: from Day 1 up to 28 days after last dose (up to approximately 23 months)

Timeline

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

  1. First posted3 Dec 2012 (estimated)
  2. Study start1 Feb 2013
  3. Primary completion17 Aug 2016
  4. Study completion17 Aug 2016

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
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739218
Sponsor's protocol ID
ML28337
Other IDs
2012-001144-22
Acronym
ANTHALYA
Status last verified
Aug 2019
First submitted
28 Nov 2012
Last updated
13 Aug 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Bevacizumab in people with Ovarian Cancer, run by Hoffmann-La Roche at 15 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 6 inclusion and 15 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Percentage of Participants with Complete Resection After IDS (time frame: After IDS (approximately 4 months from randomization)). The study lists 2 primary outcomes in all. 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 NCT01739218, which also lists 1 linked publication.

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 13 Aug 2019.

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