Clinical Trial: Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: Broto, Javier Martín, M.D.

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Broto, Javier Martín, M.D.

Dates:
Date Received: July 17, 2013
Date Started: January 2012
Date Completion: December 2015
Last Updated: October 23, 2015
Last Verified: October 2015