Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Avastin (Bevacizumab) in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Cancer, Initially Unresectable

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01739218
First received: November 28, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This randomized, open-label study will evaluate the efficacy and safety of neoad juvant Avastin (bevacizumab) in patients with initially unresectable, FIGO stage IIIC/IV ovarian, tubal or peritoneal cancer. Patients will be randomized to rec eive 8 cycles of carboplatin plus paclitaxel with or without Avastin 15 mg/kg in travenously every 3 weeks in Cycles 1 to 3 before surgery. All patients will rec eive Avastin 15 mg/kg intravenously every 3 weeks for Cycles 6 to 26. Anticipate d time on study treatment is until disease progression or unacceptable toxicity occurs, for up to a maximum of 26 cycles.


Condition Intervention Phase
Ovarian Cancer
Drug: Carboplatin
Drug: bevacizumab [Avastin]
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Complete resection rate after interval debulking surgery (IDS), defined as complete removal of all macroscopic residual tumour at IDS (Completeness of Cytoreduction Score = 0) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate before IDS (neoadjuvant phase), assessed according to RECIST v1.1 criteria and/or CA-125 levels) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Objective response rate after all courses of treatment (16 months following IDS) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: February 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Control Drug: Carboplatin
AUC 5 mg/mL/min iv every 3 weeks, Day 1 of Cycles 1-8
Drug: bevacizumab [Avastin]
15 mg/kg iv every 3 weeks, Day 1 of Cycles 6-26
Drug: paclitaxel
175 mg/m2 iv every 3 weeks, Day 1 of Cycles 1-4, and 175 mg/m2 every 3 weeks or 80 mg/m2 weekly Cycles 5-8
Experimental: Neoadjuvant Bevacizumab Drug: Carboplatin
AUC 5 mg/mL/min iv every 3 weeks, Day 1 of Cycles 1-8
Drug: bevacizumab [Avastin]
15 mg/kg iv every 3 weeks, Day 1 of Cycles 1-3
Drug: bevacizumab [Avastin]
15 mg/kg iv every 3 weeks, Day 1 of Cycles 6-26
Drug: paclitaxel
175 mg/m2 iv every 3 weeks, Day 1 of Cycles 1-4, and 175 mg/m2 every 3 weeks or 80 mg/m2 weekly Cycles 5-8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult female patients, >/= 18 years of age
  • Histologically confirmed and documented high risk stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
  • Patients are required to be deemed by a surgeon experienced in the management of ovarian cancer not to be eligible for primary complete debulking surgery during a laparoscopic procedure
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Life expectancy >/= 3 months
  • Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards
  • Patient should be beneficiary of healthcare coverage under the social security system

Exclusion Criteria:

  • Non-epithelial ovarian cancer, ovarian tumour with low malignant potential, or mucinous and clear cell ovarian cancer
  • 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 treatment (within 28 days prior to Day 1, Cycle 1) 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 (>325 mg/day)
  • Planned intraperitoneal cytotoxic chemotherapy
  • Inadequate bone marrow, liver or renal function
  • History of myocardial infarction, unstable angina, stroke or ischemic attack within 6 months prior to Day 1, Cycle 1
  • Uncontrolled hypertension
  • Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or greater congestive heart failure, aortic aneurism)
  • Pre-existing peripheral neuropathy >/= 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 enrolment, except for tumours 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739218

Contacts
Contact: Reference Study ID Number: ML28337 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
France
Recruiting
Amiens, France, 80054
Recruiting
Besancon, France, 25030
Active, not recruiting
Bordeaux, France, 33076
Recruiting
Caen, France, 14076
Active, not recruiting
Clermont Ferrand, France, 63011
Recruiting
Lille, France, 59020
Active, not recruiting
Marseille, France, 13273
Active, not recruiting
Montpellier, France, 34298
Active, not recruiting
Nice, France, 06189
Active, not recruiting
Paris, France, 75970
Recruiting
Paris, France, 75908
Active, not recruiting
Paris, France, 75231
Active, not recruiting
St Cloud, France, 92210
Recruiting
Toulouse, France, 31059
Active, not recruiting
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01739218     History of Changes
Other Study ID Numbers: ML28337, 2012-001144-22
Study First Received: November 28, 2012
Last Updated: November 24, 2014
Health Authority: France: ANSM - Agence Nationale de Sécurité du Médicament

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014