Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy

NCT01308034 | Completed Phase 1 DMC

• 2 other identifiers: RT - SUTENT2010-021551-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery. The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery. This study is a multicentre, open-label phase I with dose escalation : 2 dose levels. 3-6 patients will be included at each dose level.3-18 patients will be included in the study.

Conditions

Non GIST Sarcomas

Keywords

non GIST sarcomas; sunitinib; radiotherapy; dose escalation

Outcome Measures

Primary Outcomes (1)

• the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment

  within 14 weeks after the start of treatment

Secondary Outcomes (6)

• the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC

  within 12 months after the start of treatment

• response rate at 6 months using MRI (magnetic resonance imaging)

  6 months after the start of treatment

• progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up

  within 12 months after the start of treatment

• evolution of neo-angiogenesis during treatment measured by DCE-US

  within 6 weeks after the start of treatment

• correlation between clinical response and change of tumor perfusion measured by DCE-US

  within 12 months after the start of treatment

Study Arms (1)

association sunitinib radiotherapy

EXPERIMENTAL

Drug: sunitinib

Interventions

sunitinib DRUG

All patients will be treated with sunitinib (2 dose levels) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib. Dose level 1 : 25 mg once daily Dose level 2 : 37.5 mg once daily Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring.

association sunitinib radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \> 18 years of age
• Histologically or cytologically (in case of recurrence) confirmed connective tissue neoplasm, including any of the following subtypes:
• Liposarcomas
• Fibrosarcoma, myxofibrosarcoma
• Undifferentiated pleomorphic sarcoma
• Leiomyosarcomas
• Pleomorphic rhabdomyosarcomas only
• Angiosarcomas
• Uncertain differentiated tumors: synovial sarcomas, epithelioid sarcomas, alveolar sarcomas, clear cells sarcomas.
• or osteosarcoma diagnosis, chondrosarcoma or chordoma.
• Locally advanced or locally recurrent inoperable tumor without previous irradiation \[inoperable status must be assessed by staff including a surgeon specialized in sarcoma\].
• No prior treatment by sunitinib malate
• Life expectancy \> 6 months
• ECOG performance status ≤ 2
• Blood tests, renal and liver functions in the normal range with, in the 7 days prior to study entry, blood or serum values as follows:

You may not qualify if:

• GIST, Ewing sarcoma or embryonic rhabdomyosarcomas
• Radiation field including lung, bowel, or central nervous system
• Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication
• NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration
• Major surgical procedure, open biopsy, or serious non healing wound within 28 days prior to first day of treatment
• Concurrent participation in another clinical trial
• Other disease or illness within the past 6 months prior to study drug administration, including the following:
• Psychiatric illness or social situation that would preclude study compliance
• Known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
• Known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease
• peritoneal carcinosis
• number of metastatic sites \> 2
• Restriction of freedom by judicial or administrative decision
• Pregnant or lactating women

Sponsors & Collaborators

• Centre Leon Berard: lead
• Ministry of Health, France: collaborator

Study Sites (6)

Institut Bergonié

Bordeaux, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

CHU La Timone

Marseille, France

Location

Institut de Cancérologie de l'ouest

Saint-Herblain, France

Location

Institut Gustave Roussy

Villejuif, France

Location

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MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jean Yves Blay, PR

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

• Marie Pierre Sunyach

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 3, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: September 21, 2016
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

FR (6)