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Ovarian CancerPhase 2NCT00937560

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

A Phase 2 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hoffmann-La Roche at 55 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Bevacizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
55 sitesin 9 countries
Study dates
25 Jun 2009to 1 Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 9 countries.

55 sites in 9 countries

France18 sites

  • Centre Hospitalier Henri Duffaut; Hematologie

    Avignon, 84902

  • Clinique Tivoli; Sce Radiotherapie

    Bordeaux, 33000

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Ch De Brive La Gaillarde; Radiotherapie Oncologie

    Brive-la-Gaillarde, 19312

  • Hopital Antoine Beclere; Service de Medecine Interne

    Clamart, 92141

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

    Gap, 05000

  • Institut Daniel Hollard

    Grenoble, 38000

  • Hôpital Saint Joseph; Oncologie Medicale

    Marseille, 13285

  • CHRA;Hematologie

    Metz-Tessy, 74370

  • Centre Antoine Lacassagne; Hopital De Jour A2

    Nice, 06189

  • GH Paris Saint Joseph; Hopital De Jour Oncologie

    Paris, 75674

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Hopital De La Miletrie; Hematologie Et Oncologie Medicale

    Poitiers, 86021

  • Institut de Cancerologie de La Loire; Radiotherapie

    Saint-Priest-en-Jarez, 42271

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Centre Alexis Vautrin; Oncologie Medicale

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain9 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

    Barcelona, 08041

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

    Madrid, 28033

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

Other trials in Spain

Netherlands7 sites

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Academisch Medisch Centrum; Inwendige Geneeskunde

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente Enschede; Internal Medicine

    Enschede, 7511 JX

  • Academ Ziekenhuis Groningen; Medical Oncology

    Groningen, 9713 GZ

  • Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde

    Leidschendam, 2262 BA

  • Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde

    Tilburg, 5022 GC

  • Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

    Zwolle, 8025 AB

Other trials in Netherlands

Russia7 sites

  • Regional Clinical Oncology Dispensary

    Krasnodar, 350040

  • Oncology Hospital; Chemotherapy Dept.

    Moscow, 107005

  • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

    Moscow, 115478

  • City Clinical Oncology Hospital

    Moscow, 143423

  • Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

    Obninsk, Kaluzhskaya Region, 249034

  • St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355045

Other trials in Russia

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset; Onkology

    Gothenburg, SE-41 343

  • Uni Hospital Linkoeping; Dept. of Oncology

    Linköping, 58185

  • Örebro University Hospital; Department of Gynecologic Oncology

    Örebro, 70185

  • Norrlands Uni Hospital; Onkologi Avd.

    Umeå, 90185

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Italy4 sites

  • Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

    Campobasso, Molise, 86100

  • A.O. Universitaria Policlinico Di Modena; Oncologia

    Modena, Emilia-Romagna, 41100

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

    Naples, Campania, 80131

  • Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica

    Rome, Lazio, 00168

Other trials in Italy

Brazil2 sites

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Hospital das Clinicas - FMUSP, Oncologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Norway2 sites

  • The Norvegian Radium Hospital Montebello; Dept of Oncology

    Oslo, 0379

  • St. Olavs Hospital; Kvinneklinikken

    Trondheim, 7006

Other trials in Norway

United Kingdom1 site

  • Royal Marsden Hospital; Dept of Med-Onc

    London, SW3 6JJ

Other trials in United Kingdom

About this study

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

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.

Conditions
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab was supplied as a sterile solution for infusion.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel was supplied locally in commercial batches.

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin was supplied locally in commercial batches.

Study groups in NCT00937560
Study groupRoleWhat they receive
Bevacizumab + paclitaxel + carboplatinExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (4)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: Baseline to Year 2

  4. 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).

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2009 (estimated)
  2. Study start25 Jun 2009
  3. Primary completion31 Jul 2012
  4. Study completion1 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937560
Sponsor's protocol ID
MO22225
Other IDs
2008-008336-85, 2008
Status last verified
Oct 2017
First submitted
6 Jul 2009
Last updated
6 Nov 2017

Publications

  • 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.

    PubMed 24007819

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Ovarian Cancer, run by Hoffmann-La Roche at 55 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in France, Spain, Netherlands, Russia, Sweden and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00937560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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