Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Complete Resection After IDS
timeFrame: After IDS (approximately 4 months from randomization)
measure: Percentage of Participants with Different CC Scores After IDS
timeFrame: After IDS (approximately 4 months from randomization)
Secondary outcomes:
measure: Percentage of Participants with Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last tumor assessment (up to approximately 38 months)
measure: Percentage of Participants with Response According to Cancer Antigen (CA)-125 Levels
timeFrame: At IDS (approximately 3 months); at Cycle 26 (approximately 22 months); and at last CA-125 assessment (up to approximately 38 months)
measure: Percentage of Participants with RECIST v1.1 Objective Response and CA-125 Response
timeFrame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
measure: Percentage of Participants with RECIST v1.1 Objective Response Without CA-125 Response
timeFrame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
measure: Percentage of Participants with CA-125 Response Without RECIST v1.1 Objective Response
timeFrame: At Cycle 26 (approximately 22 months) and at last response assessment (up to approximately 38 months)
measure: Number of Participants with Disease Progression or Death From any Cause
timeFrame: From Baseline to disease progression or death due to any cause (up to approximately 38 months)
measure: Progression-Free Survival (PFS) According to RECIST v1.1
timeFrame: From Baseline to disease progression or death due to any cause (up to approximately 38 months)
measure: Percentage of Participants with Serious Adverse Events (SAEs) and Non-SAEs
timeFrame: 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)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu D'Amiens
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Bordeaux
country: France
facility: Institut Bergonie; Oncologie
city: Caen
country: France
facility: Centre Francois Baclesse; Chir Gynecologique
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Chir Generale Oncologie
city: Lille
country: France
facility: Centre Oscar Lambret; Cancerologie Gynecologique
city: Marseille
country: France
facility: Institut J Paoli I Calmettes; Chir II
city: Montpellier
country: France
facility: Centre Val Aurelle Paul Lamarque; Chir A1
city: Nice
country: France
facility: Centre Antoine Lacassagne; Hopital De Jour A2
city: Paris
country: France
facility: Institut Curie; Chir Generale Gyneco Oncologique
city: Paris
country: France
facility: Hop Europeen Georges Pompidou; Gynecologie
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: St Cloud
country: France
facility: Centre Rene Huguenin; Chir Generale Oncologique
city: Toulouse
country: France
facility: Hopital Rangueil; CHIR Generale Et Gynecologique
city: Villejuif
country: France
facility: Institut Gustave Roussy; Departement Chirurgie Generale /Unite Tarn
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: