Back to resultsTrial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum (GEIS-27)
Primary Purpose
Retroperitoneal Liposarcoma, Retroperitoneal Leiomyosarcoma, Chondrosarcoma
Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Nilotinib-adriamycin
Sponsored by
About this trial
This is an interventional treatment trial for Retroperitoneal Liposarcoma focused on measuring liposarcoma, leiomyosarcoma, retroperitoneum, chondrosarcoma
Eligibility Criteria
Inclusion Criteria:
- Patients with histological diagnosis of well differentiated liposarcoma, dedifferentiated liposarcoma or primary leiomyosarcoma of retroperitoneum and resectable. In phase I the study will recruit patients with high-grade chondrosarcoma of non-mesenchymal type.
- Age: 18-70 years.
- Measurable disease, according to RECIST criteria.
- Functional status: 0-1 (ECOG).
- Baseline medullar function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, RAN≥ 1,5 x 109 /l, granulocytes ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with alteration of transaminases ≤ 2.5 times the normal limits, bilirubin total ≤ LSN, CPK≤ 2.5 times the normal limits, alkaline phosphatase ≤ 2.5 times more the normal limits or creatinine values ≤ 1.6 mg/dL, are accepted.
- Cardiac function (LVEF) normal, considering the normal ranges of the institution.
- The patient must voluntarily sign the informed consent before any trial test, knowing that he/she can leave the trial at any time, without any consequence for his/her posterior medical attention.
- Patients in fertile age (both male and female) must use an effective contraceptive method before the entry in the study and during the trial. Moreover, women must maintain contraceptive measures up to 5 months after the treatment. Pregnancy must be ruled out though urine test (negative pregnancy test) for study enrolment.
Exclusion Criteria:
- Patients having received previous chemotherapy.
- Patient having been irradiated on the tumoral disease.
- Functional status > 1 (ECOG).
- Metastasis in any location.
- Bilirubin values over the normal level. Creatinine over 1.6 mg/dL.
- History of another oncological disease except basalioma or in situ cervical carcinoma adequately treated.
- Serious cardiovascular diseases (dyspnea >= 2 NYHA, ie.)
- Systemic pathologies limiting survival to less than 2 years, limiting patient availability, or those that, by clinical judgement, may interfere significantly with treatment toxicity.
- Bacterial, viral, or uncontrolled mycotic infectious diseases.
- Pregnant or lactating patients.
- Psychological, family, sociological or geographical situations not allowing protocol fulfilment or informed consent signature.
- Patients currently involved in other clinical trials receiving any other agent under investigation.
- Patient having participated in a clinical trial and/or having received an agent under investigation in the 30 days prior to enrolment.
- Patients requiring treatments with prolongation of QT interval as amiodarone, disopyramide, procainamide, quinidine, and sotalol.
Sites / Locations
- Hospital Universitari Son EspasesRecruiting
- Hospital Infanta CristinaRecruiting
- Hospital Universitari Germans Trials i PujolRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Provincial de CastellónRecruiting
- Hospital Universitario de CanariasRecruiting
- Complejo Asistencial Universitario de LeónRecruiting
- Hospital Puerta de HierroRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Ramón y CajalRecruiting
- Hospital Universitario Virgen de la ArrixacaRecruiting
- Complejo Hospitalario de NavarraRecruiting
- Hospital Marqués de ValdecillaRecruiting
- Hospital Clínico Universitario de SantiagoRecruiting
- Hospital Virgen del RocíoRecruiting
- Hospital Virgen de la SaludRecruiting
- Instituto Valenciano de OncologíaRecruiting
- Hospital Xeral CiesRecruiting
- Hospital Universitario Miguel ServetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nilotinib-adriamycin
Arm Description
The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
Outcomes
Primary Outcome Measures
Relapse-free survival (RFS) at 5 years
The main goal of the study is to improve relapse-free survival (RFS) and overall survival (OS) decreasing from 50% to 30% the percentage of relapse at 5 years in patients with resected retroperitoneal sarcoma.
Secondary Outcome Measures
Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR])
To determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) using RECIST 1.1 criteria
Overall survival (OS)
Overall survival measured from treatment start date until date of death, whichever the cause, assessed up to 100 months
Number of adverse events
Number and type of adverse events according to CTCAE 4.0
Full Information
NCT ID
NCT02587169
First Posted
July 17, 2013
Last Updated
October 23, 2015
Sponsor
Broto, Javier Martín, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02587169
Brief Title
Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Acronym
GEIS-27
Official Title
GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Broto, Javier Martín, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant treatment in liposarcomas and leiomyosarcomas of retroperitoneum.
The main objective of this study is to improve relapse-free survival (RFS)and overall survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with resected sarcoma of retroperitoneum.
Secondary objectives include the analysis of antitumoral activity through response rate (RECIST and tissular changes), the assessment of positive correlation between biomarkers and clinical results, the study of long term overall survival, and the analysis of the safety profile of the nilotinib-adriamycin combination.
The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks to find a positive correlation between biomarkers and clinical results in retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination.
The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with resectable retroperitoneal sarcoma. The research comprises a robust translational study as well as histological and radiological reviews.
Detailed Description
The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
Phase I includes patients with retroperitoneal liposarcoma, retroperitoneal leiomyosarcoma and chondrosarcoma. Phase II is focused on retroperitoneal liposarcoma and leiomyosarcoma only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retroperitoneal Liposarcoma, Retroperitoneal Leiomyosarcoma, Chondrosarcoma
Keywords
liposarcoma, leiomyosarcoma, retroperitoneum, chondrosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nilotinib-adriamycin
Arm Type
Experimental
Arm Description
The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
Intervention Type
Drug
Intervention Name(s)
Nilotinib-adriamycin
Other Intervention Name(s)
Nilotinib Tasigna, Doxorubicin hydrochloride
Intervention Description
The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS) at 5 years
Description
The main goal of the study is to improve relapse-free survival (RFS) and overall survival (OS) decreasing from 50% to 30% the percentage of relapse at 5 years in patients with resected retroperitoneal sarcoma.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR])
Description
To determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) using RECIST 1.1 criteria
Time Frame
Baseline and at 4 months
Title
Overall survival (OS)
Description
Overall survival measured from treatment start date until date of death, whichever the cause, assessed up to 100 months
Time Frame
100 months
Title
Number of adverse events
Description
Number and type of adverse events according to CTCAE 4.0
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histological diagnosis of well differentiated liposarcoma, dedifferentiated liposarcoma or primary leiomyosarcoma of retroperitoneum and resectable. In phase I the study will recruit patients with high-grade chondrosarcoma of non-mesenchymal type.
Age: 18-70 years.
Measurable disease, according to RECIST criteria.
Functional status: 0-1 (ECOG).
Baseline medullar function (hemoglobin > 10 g/dL, leukocytes ≥ 3.000/mm3, RAN≥ 1,5 x 109 /l, granulocytes ≥ 1.500/mm3, platelets ≥ 100.000/mm3). Patients with alteration of transaminases ≤ 2.5 times the normal limits, bilirubin total ≤ LSN, CPK≤ 2.5 times the normal limits, alkaline phosphatase ≤ 2.5 times more the normal limits or creatinine values ≤ 1.6 mg/dL, are accepted.
Cardiac function (LVEF) normal, considering the normal ranges of the institution.
The patient must voluntarily sign the informed consent before any trial test, knowing that he/she can leave the trial at any time, without any consequence for his/her posterior medical attention.
Patients in fertile age (both male and female) must use an effective contraceptive method before the entry in the study and during the trial. Moreover, women must maintain contraceptive measures up to 5 months after the treatment. Pregnancy must be ruled out though urine test (negative pregnancy test) for study enrolment.
Exclusion Criteria:
Patients having received previous chemotherapy.
Patient having been irradiated on the tumoral disease.
Functional status > 1 (ECOG).
Metastasis in any location.
Bilirubin values over the normal level. Creatinine over 1.6 mg/dL.
History of another oncological disease except basalioma or in situ cervical carcinoma adequately treated.
Serious cardiovascular diseases (dyspnea >= 2 NYHA, ie.)
Systemic pathologies limiting survival to less than 2 years, limiting patient availability, or those that, by clinical judgement, may interfere significantly with treatment toxicity.
Bacterial, viral, or uncontrolled mycotic infectious diseases.
Pregnant or lactating patients.
Psychological, family, sociological or geographical situations not allowing protocol fulfilment or informed consent signature.
Patients currently involved in other clinical trials receiving any other agent under investigation.
Patient having participated in a clinical trial and/or having received an agent under investigation in the 30 days prior to enrolment.
Patients requiring treatments with prolongation of QT interval as amiodarone, disopyramide, procainamide, quinidine, and sotalol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricio J. Ledesma, BEng
Phone
+34 648414261
Email
pledesma@sofpromed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Santiago Blasco, BSc
Phone
+34 971439900
Email
registros@sofpromed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Martín, MD, PhD
Organizational Affiliation
Spanish Sarcoma Group (GEIS)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Balearic Islands
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Martín, MD, PhD
Phone
+34 871205705
Email
javier.martin@ssib.es
First Name & Middle Initial & Last Name & Degree
Javier Martín, MD, PhD
Facility Name
Hospital Infanta Cristina
City
Badajoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Delgado, MD
Email
ignadelgado@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ignacio Delgado, MD
Facility Name
Hospital Universitari Germans Trials i Pujol
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olatz Etxaniz, MD
Email
oetxaniz@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Olatz Etxaniz, MD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio López-Pousa, MD
Email
alopezp@santpau.cat
First Name & Middle Initial & Last Name & Degree
Antonio López-Pousa, MD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Valverde, MD
Email
cmvalver@vhebron.net
First Name & Middle Initial & Last Name & Degree
Claudia Valverde, MD
Facility Name
Hospital Provincial de Castellón
City
Castellón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramón de las Peñas, MD
Email
ramon.delaspenas@hospital2000.net
First Name & Middle Initial & Last Name & Degree
Ramón de las Peñas, MD
Facility Name
Hospital Universitario de Canarias
City
La Laguna
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Cruz, MD
Email
jcruzjurado@gmail.com
First Name & Middle Initial & Last Name & Degree
Josefina Cruz, MD
Facility Name
Complejo Asistencial Universitario de León
City
León
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Miguel de Sande, MD
Email
lmgdesande@hotmail.com
First Name & Middle Initial & Last Name & Degree
Luis Miguel de Sande, MD
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Cubedo, MD
Email
rcubedo@gmail.com
First Name & Middle Initial & Last Name & Degree
Ricardo Cubedo, MD
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Redondo, MD
Email
aredondo12@gmail.com
First Name & Middle Initial & Last Name & Degree
Andrés Redondo, MD
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mª Ángeles Vaz, MD
Email
mavaz3@yahoo.es
First Name & Middle Initial & Last Name & Degree
Mª Ángeles Vaz, MD
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerónimo Martínez, MD
Email
jeronimo@seom.org
First Name & Middle Initial & Last Name & Degree
Jerónimo Martínez, MD
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Láinez, MD
Email
nuria.lainez.milagro@cfnavarra.es
First Name & Middle Initial & Last Name & Degree
Nuria Láinez, MD
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana de Juan, MD
Email
ajuan@humv.es
First Name & Middle Initial & Last Name & Degree
Ana de Juan, MD
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Vidal, MD
Email
yvidalinsua@yahoo.es
First Name & Middle Initial & Last Name & Degree
Yolanda Vidal, MD
Facility Name
Hospital Virgen del Rocío
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Sancho, MD
Email
sanchomarquez@gmail.com
First Name & Middle Initial & Last Name & Degree
Pilar Sancho, MD
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Medina, MD
Email
boladiez39@yahoo.es
First Name & Middle Initial & Last Name & Degree
Javier Medina, MD
Facility Name
Instituto Valenciano de Oncología
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Lavernia, MD
Email
javilavernia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Javier Lavernia, MD
Facility Name
Hospital Xeral Cies
City
Vigo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Antonio Carrasco, MD
Email
juan.antonio.carrasco.alvarez@sergas.es
First Name & Middle Initial & Last Name & Degree
Juan Antonio Carrasco, MD
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Martínez-Trufero, MD
Email
jmtrufero@seom.org
First Name & Middle Initial & Last Name & Degree
Javier Martínez-Trufero, MD
12. IPD Sharing Statement
Links:
URL
http://www.grupogeis.org
Description
Spanish Sarcoma Group (GEIS)
Learn more about this trial
Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
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