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

Purpose

This single arm study will evaluate the efficacy and safety of first line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus Avastin in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer. patients will receive 6 to 9 x 3-week cycles of treatment with Avastin (7.5mg/kg iv on day 1 of each cycle), paclitaxel (80mg/m2 iv on days 1, 8 and 15 of each cycle) and carboplatin (iv to an AUC of 6 on day 1 of each cycle).Following combination chemotherapy, Avastin may continue to be given as monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Bevacizumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival [ Time Frame: assessed after cycles 3,6 and 9 of triple treatment and every 18 weeks on maintenance monotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate, duration of response, overall survival, biological progression-free interval [ Time Frame: assessed after cycles 3,6 and 9 of triple treatment and every 18 weeks on maintenance monotherapy ] [ Designated as safety issue: No ]
Adverse events, cardiac events, lab parameters, ECOG performance status, vital signs [ Time Frame: Throughout study, laboratory and EOCG assessments every 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	186
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: bevacizumab [Avastin] 7.5mg/kg iv on day 1 of each 3 week cycle Drug: paclitaxel 80mg/m2 iv on days 1, 8 and 15 of each 3 week cycle Drug: carboplatin iv infusion to an AUC of 6 on day 1 of each 3 week cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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;
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937560

Hide Study Locations

Locations

Brazil

JAU, Brazil, 17210-080

Sao Paulo, Brazil, 05403-000
France

Avignon, France, 84902

Bordeaux, France, 33000

Bordeaux, France, 33300

Brive, France, 19312

Clamart, France, 92141

Dijon, France, 21079

GAP, France, 05007

Grenoble, France, 38000

Marseille, France, 13285

Nice, France, 06189

Paris, France, 75970

Paris, France, 75674

Poitiers, France, 86021

Pringy, France, 74370

St-priest-en-jarez, France, 42271

Strasbourg, France, 67065

Toulouse, France, 31052

Vandoeuvre-les-nancy, France, 54511
Italy

Campobasso, Italy, 86100

Modena, Italy, 41100

Napoli, Italy, 80131

Roma, Italy, 00168
Netherlands

Alkmaar, Netherlands, 1815 JD

Amsterdam, Netherlands, 1105 AZ

Enschede, Netherlands, 7511 JX

Groningen, Netherlands, 9713 GZ

Leidschendam, Netherlands, 2262 BA

Tilburg, Netherlands, 5022 GC

Zwolle, Netherlands, 8025 AB
Norway

Oslo, Norway, 0310

Trondheim, Norway, 7052
Russian Federation

Krasnodar, Russian Federation, 350080

Moscow, Russian Federation, 143423

Moscow, Russian Federation, 115478

Moscow, Russian Federation, 107005

Obninsk, Kaluzhskaya Region, Russian Federation, 249034

Saint-petersburg, Russian Federation, 197022

Stavropol, Russian Federation, 355045
Spain

Barcelona, Spain, 08025

Barcelona, Spain, 08035

Madrid, Spain, 28041

Madrid, Spain, 28040

Madrid, Spain, 28046

Madrid, Spain, 28033

Málaga, Spain, 29010

Valencia, Spain, 46010

Valencia, Spain, 46009
Sweden

Göteborg, Sweden, 41345

Linkoeping, Sweden, 58185

Umea, Sweden, 90185

Uppsala, Sweden, 75185

Örebro, Sweden, 70185
United Kingdom

London, United Kingdom, SW3 6JJ

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:	NCT00937560 History of Changes
Other Study ID Numbers:	MO22225, 2008-008336-85
Study First Received:	July 6, 2009
Last Updated:	May 7, 2013
Health Authority:	Spain: Ministry of Health

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Carboplatin
Paclitaxel

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013