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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739218
First Posted: December 3, 2012
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants with Complete Resection After IDS [ Time Frame: 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) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Enrollment: 99
Actual Study Start Date: February 1, 2013
Study Completion Date: August 17, 2016
Primary Completion Date: August 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Avastin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739218


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01739218     History of Changes
Other Study ID Numbers: ML28337
2012-001144-22 ( EudraCT Number )
First Submitted: November 28, 2012
First Posted: December 3, 2012
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors