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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.

Tracking Information
First Submitted Date  ICMJE July 17, 2013
First Posted Date  ICMJE October 27, 2015
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
  • 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
  • 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
  • Number of adverse events [ Time Frame: 4 months ]
    Number and type of adverse events according to CTCAE 4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Official Title  ICMJE GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Retroperitoneal Liposarcoma
  • Retroperitoneal Leiomyosarcoma
  • Chondrosarcoma
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Nilotinib-adriamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02587169
Other Study ID Numbers  ICMJE EC10-150 RETRONEO
2011-002368-26 ( EudraCT Number )
GEIS-27 ( Other Identifier: Spanish Sarcoma Group (GEIS) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Broto, Javier Martín, M.D.
Study Sponsor  ICMJE Broto, Javier Martín, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Javier Martín, MD, PhD Spanish Sarcoma Group (GEIS)
PRS Account Broto, Javier Martín, M.D.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP