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

NCT01739218 | Completed Phase 2 DMC

• 2 other identifiers: ML283372012-001144-22
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Complete Resection After IDS

  After IDS (approximately 4 months from randomization)

• Percentage of Participants with Different CC Scores After IDS

  After IDS (approximately 4 months from randomization)

Secondary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Carboplatin + Paclitaxel + Bevacizumab

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Bevacizumab

Carboplatin + Paclitaxel

ACTIVE COMPARATOR

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; Drug: Paclitaxel; Drug: Bevacizumab

Interventions

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).

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Bevacizumab

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).

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Bevacizumab

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.

Also known as: Avastin

Carboplatin + Paclitaxel; Carboplatin + Paclitaxel + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Chu D'Amiens

Amiens, 80054, France

Location

HOPITAL JEAN MINJOZ; Oncologie

Besançon, 25030, France

Location

Institut Bergonie; Oncologie

Bordeaux, 33076, France

Location

Centre Francois Baclesse; Chir Gynecologique

Caen, 14076, France

Location

Centre Jean Perrin; Chir Generale Oncologie

Clermont-Ferrand, 63011, France

Location

Centre Oscar Lambret; Cancerologie Gynecologique

Lille, 59020, France

Location

Institut J Paoli I Calmettes; Chir II

Marseille, 13273, France

Location

Centre Val Aurelle Paul Lamarque; Chir A1

Montpellier, 34298, France

Location

Centre Antoine Lacassagne; Hopital De Jour A2

Nice, 06189, France

Location

Institut Curie; Chir Generale Gyneco Oncologique

Paris, 75231, France

Location

Hop Europeen Georges Pompidou; Gynecologie

Paris, 75908, France

Location

HOPITAL TENON; Cancerologie Medicale

Paris, 75970, France

Location

Centre Rene Huguenin; Chir Generale Oncologique

Saint-Cloud, 92210, France

Location

Hopital Rangueil; CHIR Generale Et Gynecologique

Toulouse, 31059, France

Location

Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 37185961 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Paclitaxel; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 3, 2012
• Study Start: February 1, 2013
• Primary Completion: August 17, 2016
• Study Completion: August 17, 2016
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)