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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937560
• Other study ID #: MO22225
• Secondary ID: 2008-008336-85
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: October 5, 2017
• Start date: June 25, 2009
• Est. completion date: July 1, 2013

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: July 1, 2013
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab
Bevacizumab was supplied as a sterile solution for infusion.
• Paclitaxel
Paclitaxel was supplied locally in commercial batches.
• Carboplatin
Carboplatin was supplied locally in commercial batches.

Locations

Country	Name	City	State
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital das Clinicas - FMUSP, Oncologia	Sao Paulo	SP
France	Centre Hospitalier Henri Duffaut; Hematologie	Avignon
France	Clinique Tivoli; Sce Radiotherapie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie	Bordeaux
France	Ch De Brive La Gaillarde; Radiotherapie Oncologie	Brive La Gaillarde
France	Hopital Antoine Beclere; Service de Medecine Interne	Clamart
France	Centre Georges Francois Leclerc; Oncologie 3	Dijon
France	Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente	GAP
France	Institut Daniel Hollard	Grenoble
France	Hôpital Saint Joseph; Oncologie Medicale	Marseille
France	CHRA;Hematologie	Metz Tessy
France	Centre Antoine Lacassagne; Hopital De Jour A2	Nice
France	GH Paris Saint Joseph; Hopital De Jour Oncologie	Paris
France	HOPITAL TENON; Cancerologie Medicale	Paris
France	Hopital De La Miletrie; Hematologie Et Oncologie Medicale	Poitiers
France	Institut de Cancerologie de La Loire; Radiotherapie	St Priest En Jarez
France	Centre Paul Strauss; Oncologie Medicale	Strasbourg
France	Institut Claudius Regaud; Departement Oncologie Medicale	Toulouse
France	Centre Alexis Vautrin; Oncologie Medicale	Vandoeuvre Les Nancy
Italy	Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica	Campobasso	Molise
Italy	A.O. Universitaria Policlinico Di Modena; Oncologia	Modena	Emilia-Romagna
Italy	IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B	Napoli	Campania
Italy	Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica	Roma	Lazio
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Academisch Medisch Centrum; Inwendige Geneeskunde	Amsterdam
Netherlands	Medisch Spectrum Twente Enschede; Internal Medicine	Enschede
Netherlands	Academ Ziekenhuis Groningen; Medical Oncology	Groningen
Netherlands	Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde	Leidschendam
Netherlands	Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde	Tilburg
Netherlands	Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde	Zwolle
Norway	The Norvegian Radium Hospital Montebello; Dept of Oncology	Oslo
Norway	St. Olavs Hospital; Kvinneklinikken	Trondheim
Russian Federation	Regional Clinical Oncology Dispensary	Krasnodar
Russian Federation	City Clinical Oncology Hospital	Moscow
Russian Federation	Oncology Hospital; Chemotherapy Dept.	Moscow
Russian Federation	Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy	Moscow
Russian Federation	Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease	Obninsk, Kaluzhskaya Region
Russian Federation	St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary	Saint-Petersburg
Russian Federation	SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary	Stavropol
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	Centro Oncologico MD Anderson Internacional; Servicio de Oncologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Sweden	Sahlgrenska Universitetssjukhuset; Onkology	Gothenburg
Sweden	Uni Hospital Linkoeping; Dept. of Oncology	Linköping
Sweden	Örebro University Hospital; Department of Gynecologic Oncology	Örebro
Sweden	Norrlands Uni Hospital; Onkologi Avd.	Umea
Sweden	Akademiska sjukhuset, Onkologkliniken	Uppsala
United Kingdom	Royal Marsden Hospital; Dept of Med-Onc	London

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Brazil,  France,  Italy,  Netherlands,  Norway,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	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	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.	Baseline to Year 2
Secondary	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).	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)