Clinical trial NCT02743221: A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Official title: An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic
colorectal
cancer
untreated
first-line
S95005 (Trifluridine/tipiracil)
bevacizumab
capecitabine
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2016-04-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained.
* Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* RAS status must have been determined (mutant or wild).
* Has at least one measurable metastatic lesion.
* No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
* Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
* Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
* Is able to take medication orally (i.e., no feeding tube).
* Has adequate organ function.
* Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
* Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.

Exclusion Criteria:

* Is a pregnant or lactating female.
* Has certain serious illness or serious medical condition(s) as described in the protocol.
* Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
* Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
* Has contra-indication to bevacizumab or capecitabine.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
measure: Duration of Response (DR)
timeFrame: Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)
measure: Disease Control Rate (DCR)
timeFrame: Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)
measure: Overall Survival (OS)
timeFrame: Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Oncology
city: Heidelberg
country: Australia
facility: Austin Hospital Olivia Newton-John Cancer & Wellness Centre
city: Saint Albans
country: Australia
facility: Western Health, Sunshine Hospital
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital Haematology and Oncology Unit
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi Oncologie-Hématologie
city: Leuven
country: Belgium
facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie
city: Liège
country: Belgium
facility: CHC Saint-Joseph Oncologie-Hématoimmunopathologie
city: Barretos
country: Brazil
facility: Hospital do Câncer de Barretos - Fundação Pio XII
city: Ijui
country: Brazil
facility: Centro de Pesquisa Hospital de Caridade de Ijuí
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base, Centro Intergrado de Pesquisa
city: Sao Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Dpt of Oncology
city: Odense
country: Denmark
facility: Odense Universitetshospital - Department of Oncology
city: Besançon
country: France
facility: CHU Jean Minjoz, Service d'oncologie médicale
city: Paris
country: France
facility: Hôpital Saint Antoine, oncology department
city: Saint-Herblain
country: France
facility: Centre René Gauducheau, Oncologie Médicale
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Magdeburg
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie
city: Munich
country: Germany
facility: Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology
city: Genova
country: Italy
facility: A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1
city: Milan
country: Italy
facility: A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck
city: Naples
country: Italy
facility: Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia
city: Pisa
country: Italy
facility: .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2
city: Amsterdam
country: Netherlands
facility: AMC Academisch Medisch Centrum Medische Oncologie
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis, Interne Geneeskunde/Oncologie
city: Groningen
country: Netherlands
facility: Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1
city: Hilversum
country: Netherlands
facility: Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum Interne Geneeskunde
city: Utrecht
country: Netherlands
facility: Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie
city: Venlo
country: Netherlands
facility: VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii
city: Warszawa
country: Poland
facility: NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center n.a. NN Blokhin
city: Moscow
country: Russian Federation
facility: Moscow City Oncology Hospital # 62, Chemotherapy
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines
city: St Petersburg
country: Russian Federation
facility: Scientific Centre for Specialized Medical Care (oncological)
city: Barcelona
country: Spain
facility: Hospital Valle de Hebrón, Servicio de Oncología
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia, Deparatmento Oncología Médica
city: Hospitalet de Llobregat
country: Spain
facility: Instituto Catalan De Oncología, Hospitalet de Llobregat
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal, Oncología Médica
city: Madrid
country: Spain
facility: H. Universitario La Paz Oncología Médica
city: Malaga
country: Spain
facility: Hospital General Universitario, Oncología Médica
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra, Oncología Médica
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre GI cancers
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, The HOPE Clinical Trials Unit
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Imperial healthcare NHS Trust Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust, GI & Endocrine
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital Department of Oncology
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Leuven Cancer Institute, University Hospitals Leuven
name: Eric Van Custem, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Fougeray R, Egorov A, Amellal N, Moiseyenko V. First-line trifluridine/tipiracil + bevacizumab in patients with unresectable metastatic colorectal cancer: final survival analysis in the TASCO1 study. Br J Cancer. 2022 Jun;126(11):1548-1554. doi: 10.1038/s41416-022-01737-2. Epub 2022 Apr 19.
citation: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.