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A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00937560
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : February 24, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Bevacizumab Drug: Paclitaxel Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Phase II Clinical Study Investigating the Addition of Bevacizumab to Carboplatin and Weekly Paclitaxel as First-line Treatment in Patients With Epithelial Ovarian Cancer
Actual Study Start Date : June 25, 2009
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : July 1, 2013


Arm Intervention/treatment
Experimental: Bevacizumab + paclitaxel + carboplatin
Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile solution for infusion.
Other Name: Avastin

Drug: Paclitaxel
Paclitaxel was supplied locally in commercial batches.
Other Name: Taxol

Drug: Carboplatin
Carboplatin was supplied locally in commercial batches.
Other Name: Paraplatin




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) ]
    Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.


Secondary Outcome Measures :
  1. Percentage of Participants With an Objective Response [ Time Frame: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) ]
    An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.

  2. Duration of Response [ Time Frame: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) ]
    Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.

  3. Overall Survival at 1 Year and 2 Years [ Time Frame: Baseline to Year 2 ]
    Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.

  4. Biological Progression-free Interval [ Time Frame: Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) ]
    Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).



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

Inclusion Criteria

  • Female patients, ≥ 18 years of age.
  • Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Initial surgery, but no chemotherapy or radiotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

  • Non-epithelial tumors.
  • Ovarian tumors with low malignant potential.
  • Previous systemic anti-cancer therapy for ovarian cancer.
  • History or evidence of synchronous primary endometrial cancer.
  • Current or recent daily treatment with aspirin (> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.

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): NCT00937560


  Hide Study Locations
Locations
Brazil
Hospital Amaral Carvalho
Jau, SP, Brazil, 17210-080
Hospital das Clinicas - FMUSP, Oncologia
Sao Paulo, SP, Brazil, 05403-000
France
Centre Hospitalier Henri Duffaut; Hematologie
Avignon, France, 84902
Clinique Tivoli; Sce Radiotherapie
Bordeaux, France, 33000
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, France, 33077
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive La Gaillarde, France, 19312
Hopital Antoine Beclere; Service de Medecine Interne
Clamart, France, 92141
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France, 21079
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
GAP, France, 05000
Institut Daniel Hollard
Grenoble, France, 38000
Hôpital Saint Joseph; Oncologie Medicale
Marseille, France, 13285
CHRA;Hematologie
Metz Tessy, France, 74370
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France, 06189
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, France, 75674
HOPITAL TENON; Cancerologie Medicale
Paris, France, 75970
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers, France, 86021
Institut de Cancerologie de La Loire; Radiotherapie
St Priest En Jarez, France, 42271
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre Les Nancy, France, 54511
Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
Napoli, Campania, Italy, 80131
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena, Emilia-Romagna, Italy, 41100
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Roma, Lazio, Italy, 00168
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
Campobasso, Molise, Italy, 86100
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
Academisch Medisch Centrum; Inwendige Geneeskunde
Amsterdam, Netherlands, 1105 AZ
Medisch Spectrum Twente Enschede; Internal Medicine
Enschede, Netherlands, 7511 JX
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, Netherlands, 9713 GZ
Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
Leidschendam, Netherlands, 2262 BA
Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
Tilburg, Netherlands, 5022 GC
Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
Zwolle, Netherlands, 8025 AB
Norway
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, Norway, 0379
St. Olavs Hospital; Kvinneklinikken
Trondheim, Norway, 7006
Russian Federation
Regional Clinical Oncology Dispensary
Krasnodar, Russian Federation, 350040
Oncology Hospital; Chemotherapy Dept.
Moscow, Russian Federation, 107005
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
Moscow, Russian Federation, 115478
City Clinical Oncology Hospital
Moscow, Russian Federation, 143423
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
Obninsk, Kaluzhskaya Region, Russian Federation, 249034
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russian Federation, 355045
Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, Spain, 08041
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, Spain, 28033
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sweden
Sahlgrenska Universitetssjukhuset; Onkology
Gothenburg, Sweden, SE-41 343
Uni Hospital Linkoeping; Dept. of Oncology
Linköping, Sweden, 58185
Norrlands Uni Hospital; Onkologi Avd.
Umea, Sweden, 90185
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 75185
Örebro University Hospital; Department of Gynecologic Oncology
Örebro, Sweden, 70185
United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00937560     History of Changes
Other Study ID Numbers: MO22225
2008-008336-85 ( EudraCT Number )
First Posted: July 13, 2009    Key Record Dates
Results First Posted: February 24, 2015
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
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