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

Ovarian Cancer Clinical Trial

— ANTHALYA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739218
• Other study ID #: ML28337
• Secondary ID: 2012-001144-22
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2013
• Est. completion date: August 17, 2016

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 17, 2016
• Est. primary completion date: August 17, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer

Intervention

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).
• 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).
• 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.

Locations

Country	Name	City	State
France	Chu D'Amiens	Amiens
France	HOPITAL JEAN MINJOZ; Oncologie	Besancon
France	Institut Bergonie; Oncologie	Bordeaux
France	Centre Francois Baclesse; Chir Gynecologique	Caen
France	Centre Jean Perrin; Chir Generale Oncologie	Clermont Ferrand
France	Centre Oscar Lambret; Cancerologie Gynecologique	Lille
France	Institut J Paoli I Calmettes; Chir II	Marseille
France	Centre Val Aurelle Paul Lamarque; Chir A1	Montpellier
France	Centre Antoine Lacassagne; Hopital De Jour A2	Nice
France	Hop Europeen Georges Pompidou; Gynecologie	Paris
France	HOPITAL TENON; Cancerologie Medicale	Paris
France	Institut Curie; Chir Generale Gyneco Oncologique	Paris
France	Centre Rene Huguenin; Chir Generale Oncologique	St Cloud
France	Hopital Rangueil; CHIR Generale Et Gynecologique	Toulouse
France	Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Complete Resection After IDS		After IDS (approximately 4 months from randomization)
Primary	Percentage of Participants with Different CC Scores After IDS		After IDS (approximately 4 months from randomization)
Secondary	Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)		At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)
Secondary	Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels		At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)
Secondary	Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response		At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Secondary	Percentage of Participants with RECIST v1.1 Objective Response Without CA-125 Response		At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Secondary	Percentage of Participants with CA-125 Response Without RECIST v1.1 Objective Response		At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
Secondary	Number of Participants with Disease Progression or Death From any Cause		From Baseline to disease progression or death due to any cause (up to approximately 38 months)
Secondary	Progression-Free Survival (PFS) According to RECIST v1.1		From Baseline to disease progression or death due to any cause (up to approximately 38 months)
Secondary	Percentage of Participants with Serious Adverse Events (SAEs) and Non-SAEs		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)