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 (ANTHALYA)

August 9, 2019 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU d'Amiens
      • Besancon, France, 25030
        • HOPITAL JEAN MINJOZ; Oncologie
      • Bordeaux, France, 33076
        • Institut Bergonie; Oncologie
      • Caen, France, 14076
        • Centre Francois Baclesse; Chir Gynecologique
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin; Chir Generale Oncologie
      • Lille, France, 59020
        • Centre Oscar Lambret; Cancerologie Gynecologique
      • Marseille, France, 13273
        • Institut J Paoli I Calmettes; Chir II
      • Montpellier, France, 34298
        • Centre Val Aurelle Paul Lamarque; Chir A1
      • Nice, France, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, France, 75231
        • Institut Curie; Chir Generale Gyneco Oncologique
      • Paris, France, 75908
        • Hop Europeen Georges Pompidou; Gynecologie
      • St Cloud, France, 92210
        • Centre Rene Huguenin; Chir Generale Oncologique
      • Toulouse, France, 31059
        • Hopital Rangueil; CHIR Generale Et Gynecologique
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carboplatin + Paclitaxel + Bevacizumab
Participants 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).
Drug: Carboplatin
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).
Drug: Paclitaxel
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).
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram [mg/kg] as IV infusion over 30-90 min every 3 weeks.
Other Names:
  • Avastin
ACTIVE_COMPARATOR: Carboplatin + Paclitaxel
Participants 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.
Drug: Carboplatin
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).
Drug: Paclitaxel
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).
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15 milligrams per kilogram [mg/kg] as IV infusion over 30-90 min every 3 weeks.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Complete Resection After IDS
Time Frame: After IDS (approximately 4 months from randomization)
After IDS (approximately 4 months from randomization)
Percentage of Participants with Different CC Scores After IDS
Time Frame: After IDS (approximately 4 months from randomization)
After IDS (approximately 4 months from randomization)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)
At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)
Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels
Time Frame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)
At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)
Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response
Time Frame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Percentage of Participants with RECIST v1.1 Objective Response Without CA-125 Response
Time Frame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Percentage of Participants with CA-125 Response Without RECIST v1.1 Objective Response
Time Frame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Number of Participants with Disease Progression or Death From any Cause
Time Frame: From Baseline to disease progression or death due to any cause (up to approximately 38 months)
From Baseline to disease progression or death due to any cause (up to approximately 38 months)
Progression-Free Survival (PFS) According to RECIST v1.1
Time Frame: From Baseline to disease progression or death due to any cause (up to approximately 38 months)
From Baseline to disease progression or death due to any cause (up to approximately 38 months)
Percentage of Participants with Serious Adverse Events (SAEs) and Non-SAEs
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

August 17, 2016

Study Completion (ACTUAL)

August 17, 2016

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (ESTIMATE)

December 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28337
  • 2012-001144-22 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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