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NCT Number: NCT01739218

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Chu D'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin

Drug

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).

paclitaxel

Drug

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).

Bevacizumab

Drug

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

Primary outcomes

  1. Percentage of Participants with Complete Resection After IDS

    Time frame: After IDS (approximately 4 months from randomization)

  2. Percentage of Participants with Different CC Scores After IDS

    Time frame: After IDS (approximately 4 months from randomization)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: ANTHALYA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2012
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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