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Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum (GEIS-27)

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ClinicalTrials.gov Identifier: NCT02587169
Recruitment Status : Unknown
Verified October 2015 by Broto, Javier Martín, M.D..
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Broto, Javier Martín, M.D.

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.


Condition or disease Intervention/treatment Phase
Retroperitoneal Liposarcoma Retroperitoneal Leiomyosarcoma Chondrosarcoma Drug: Nilotinib-adriamycin Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Nilotinib-adriamycin
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).
Drug: Nilotinib-adriamycin
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).
Other Names:
  • Nilotinib Tasigna
  • Doxorubicin hydrochloride




Primary Outcome Measures :
  1. Relapse-free survival (RFS) at 5 years [ Time Frame: 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 :
  1. Objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) [ Time Frame: Baseline and at 4 months ]
    To determine the objective response rate (ORR) (confirmed complete response [CR] and partial response [PR]) using RECIST 1.1 criteria

  2. Overall survival (OS) [ Time Frame: 100 months ]
    Overall survival measured from treatment start date until date of death, whichever the cause, assessed up to 100 months

  3. Number of adverse events [ Time Frame: 4 months ]
    Number and type of adverse events according to CTCAE 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587169


Contacts
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Contact: Patricio J. Ledesma, BEng +34 648414261 pledesma@sofpromed.com
Contact: Santiago Blasco, BSc +34 971439900 registros@sofpromed.com

Locations
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Spain
Hospital Universitari Son Espases Recruiting
Palma de Mallorca, Balearic Islands, Spain
Contact: Javier Martín, MD, PhD    +34 871205705    javier.martin@ssib.es   
Principal Investigator: Javier Martín, MD, PhD         
Hospital Infanta Cristina Recruiting
Badajoz, Spain
Contact: Ignacio Delgado, MD       ignadelgado@hotmail.com   
Principal Investigator: Ignacio Delgado, MD         
Hospital Universitari Germans Trials i Pujol Recruiting
Badalona, Spain
Contact: Olatz Etxaniz, MD       oetxaniz@iconcologia.net   
Principal Investigator: Olatz Etxaniz, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Antonio López-Pousa, MD       alopezp@santpau.cat   
Principal Investigator: Antonio López-Pousa, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Claudia Valverde, MD       cmvalver@vhebron.net   
Principal Investigator: Claudia Valverde, MD         
Hospital Provincial de Castellón Recruiting
Castellón, Spain
Contact: Ramón de las Peñas, MD       ramon.delaspenas@hospital2000.net   
Principal Investigator: Ramón de las Peñas, MD         
Hospital Universitario de Canarias Recruiting
La Laguna, Spain
Contact: Josefina Cruz, MD       jcruzjurado@gmail.com   
Principal Investigator: Josefina Cruz, MD         
Complejo Asistencial Universitario de León Recruiting
León, Spain
Contact: Luis Miguel de Sande, MD       lmgdesande@hotmail.com   
Principal Investigator: Luis Miguel de Sande, MD         
Hospital Puerta de Hierro Recruiting
Madrid, Spain
Contact: Ricardo Cubedo, MD       rcubedo@gmail.com   
Principal Investigator: Ricardo Cubedo, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Andrés Redondo, MD       aredondo12@gmail.com   
Principal Investigator: Andrés Redondo, MD         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
Contact: Mª Ángeles Vaz, MD       mavaz3@yahoo.es   
Principal Investigator: Mª Ángeles Vaz, MD         
Hospital Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain
Contact: Jerónimo Martínez, MD       jeronimo@seom.org   
Principal Investigator: Jerónimo Martínez, MD         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Contact: Nuria Láinez, MD       nuria.lainez.milagro@cfnavarra.es   
Principal Investigator: Nuria Láinez, MD         
Hospital Marqués de Valdecilla Recruiting
Santander, Spain
Contact: Ana de Juan, MD       ajuan@humv.es   
Principal Investigator: Ana de Juan, MD         
Hospital Clínico Universitario de Santiago Recruiting
Santiago de Compostela, Spain
Contact: Yolanda Vidal, MD       yvidalinsua@yahoo.es   
Principal Investigator: Yolanda Vidal, MD         
Hospital Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Pilar Sancho, MD       sanchomarquez@gmail.com   
Principal Investigator: Pilar Sancho, MD         
Hospital Virgen de la Salud Recruiting
Toledo, Spain
Contact: Javier Medina, MD       boladiez39@yahoo.es   
Principal Investigator: Javier Medina, MD         
Instituto Valenciano de Oncología Recruiting
Valencia, Spain
Contact: Javier Lavernia, MD       javilavernia@hotmail.com   
Principal Investigator: Javier Lavernia, MD         
Hospital Xeral Cies Recruiting
Vigo, Spain
Contact: Juan Antonio Carrasco, MD       juan.antonio.carrasco.alvarez@sergas.es   
Principal Investigator: Juan Antonio Carrasco, MD         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain
Contact: Javier Martínez-Trufero, MD       jmtrufero@seom.org   
Principal Investigator: Javier Martínez-Trufero, MD         
Sponsors and Collaborators
Broto, Javier Martín, M.D.
Investigators
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Study Director: Javier Martín, MD, PhD Spanish Sarcoma Group (GEIS)

Additional Information:
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Responsible Party: Broto, Javier Martín, M.D.
ClinicalTrials.gov Identifier: NCT02587169     History of Changes
Other Study ID Numbers: EC10-150 RETRONEO
2011-002368-26 ( EudraCT Number )
GEIS-27 ( Other Identifier: Spanish Sarcoma Group (GEIS) )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Broto, Javier Martín, M.D.:
liposarcoma
leiomyosarcoma
retroperitoneum
chondrosarcoma

Additional relevant MeSH terms:
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Leiomyosarcoma
Liposarcoma
Chondrosarcoma
Retroperitoneal Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective Tissue
Abdominal Neoplasms
Neoplasms by Site
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action