Back to resultsA Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility 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.
Sites / Locations
- Hospital Amaral Carvalho
- Hospital das Clinicas - FMUSP, Oncologia
- Centre Hospitalier Henri Duffaut; Hematologie
- Clinique Tivoli; Sce Radiotherapie
- Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
- Ch De Brive La Gaillarde; Radiotherapie Oncologie
- Hopital Antoine Beclere; Service de Medecine Interne
- Centre Georges Francois Leclerc; Oncologie 3
- Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
- Institut Daniel Hollard
- Hôpital Saint Joseph; Oncologie Medicale
- CHRA;Hematologie
- Centre Antoine Lacassagne; Hopital De Jour A2
- GH Paris Saint Joseph; Hopital De Jour Oncologie
- HOPITAL TENON; Cancerologie Medicale
- Hopital De La Miletrie; Hematologie Et Oncologie Medicale
- Institut de Cancerologie de La Loire; Radiotherapie
- Centre Paul Strauss; Oncologie Medicale
- Institut Claudius Regaud; Departement Oncologie Medicale
- Centre Alexis Vautrin; Oncologie Medicale
- IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
- A.O. Universitaria Policlinico Di Modena; Oncologia
- Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
- Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
- Medisch Centrum Alkmaar
- Academisch Medisch Centrum; Inwendige Geneeskunde
- Medisch Spectrum Twente Enschede; Internal Medicine
- Academ Ziekenhuis Groningen; Medical Oncology
- Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
- Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
- Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
- The Norvegian Radium Hospital Montebello; Dept of Oncology
- St. Olavs Hospital; Kvinneklinikken
- Regional Clinical Oncology Dispensary
- Oncology Hospital; Chemotherapy Dept.
- Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
- City Clinical Oncology Hospital
- Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
- St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
- SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
- Hospital Universitario Clínico San Carlos; Servicio de Oncologia
- Hospital Universitario La Paz; Servicio de Oncologia
- Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
- Instituto Valenciano Oncologia; Oncologia Medica
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
- Sahlgrenska Universitetssjukhuset; Onkology
- Uni Hospital Linkoeping; Dept. of Oncology
- Norrlands Uni Hospital; Onkologi Avd.
- Akademiska sjukhuset, Onkologkliniken
- Örebro University Hospital; Department of Gynecologic Oncology
- Royal Marsden Hospital; Dept of Med-Onc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bevacizumab + paclitaxel + carboplatin
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression-free Survival
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
Percentage of Participants With an Objective Response
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.
Duration of Response
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.
Overall Survival at 1 Year and 2 Years
Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.
Biological Progression-free Interval
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937560
Brief Title
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 25, 2009 (Actual)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
July 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + paclitaxel + carboplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab was supplied as a sterile solution for infusion.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel was supplied locally in commercial batches.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin was supplied locally in commercial batches.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response
Description
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.
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)
Title
Duration of Response
Description
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.
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)
Title
Overall Survival at 1 Year and 2 Years
Description
Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.
Time Frame
Baseline to Year 2
Title
Biological Progression-free Interval
Description
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).
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Amaral Carvalho
City
Jau
State/Province
SP
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP, Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Centre Hospitalier Henri Duffaut; Hematologie
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Clinique Tivoli; Sce Radiotherapie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Ch De Brive La Gaillarde; Radiotherapie Oncologie
City
Brive La Gaillarde
ZIP/Postal Code
19312
Country
France
Facility Name
Hopital Antoine Beclere; Service de Medecine Interne
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Centre Georges Francois Leclerc; Oncologie 3
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente
City
GAP
ZIP/Postal Code
05000
Country
France
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hôpital Saint Joseph; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
CHRA;Hematologie
City
Metz Tessy
ZIP/Postal Code
74370
Country
France
Facility Name
Centre Antoine Lacassagne; Hopital De Jour A2
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
GH Paris Saint Joseph; Hopital De Jour Oncologie
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
HOPITAL TENON; Cancerologie Medicale
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut de Cancerologie de La Loire; Radiotherapie
City
St Priest En Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Centre Paul Strauss; Oncologie Medicale
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Oncologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86100
Country
Italy
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Academisch Medisch Centrum; Inwendige Geneeskunde
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente Enschede; Internal Medicine
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
Facility Name
Academ Ziekenhuis Groningen; Medical Oncology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
The Norvegian Radium Hospital Montebello; Dept of Oncology
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
St. Olavs Hospital; Kvinneklinikken
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Regional Clinical Oncology Dispensary
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Oncology Hospital; Chemotherapy Dept.
City
Moscow
ZIP/Postal Code
107005
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Oncology Hospital
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease
City
Obninsk, Kaluzhskaya Region
ZIP/Postal Code
249034
Country
Russian Federation
Facility Name
St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
City
Stavropol
ZIP/Postal Code
355045
Country
Russian Federation
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Instituto Valenciano Oncologia; Oncologia Medica
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset; Onkology
City
Gothenburg
ZIP/Postal Code
SE-41 343
Country
Sweden
Facility Name
Uni Hospital Linkoeping; Dept. of Oncology
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Norrlands Uni Hospital; Onkologi Avd.
City
Umea
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Akademiska sjukhuset, Onkologkliniken
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Örebro University Hospital; Department of Gynecologic Oncology
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Royal Marsden Hospital; Dept of Med-Onc
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24007819
Citation
Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2.
Results Reference
derived
Learn more about this trial
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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