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

Phase 1
18 Years
Open (Enrolling)
Non GIST Sarcomas

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Trial Information

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

Study design : 3 dose levels

Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily Step 3 : 50 mg once daily

3-6 patients will be included at each of the sunitinib dose levels, depending on the number
of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment

DLT is defined as :

any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any
other toxicity > or = 4

Secondary objectives are :

- to evaluate the safety with late toxicities

- to estimate the response rate at 6 months

- to estimate the progression free survival

- to evaluate the proportion of patients with an operable tumour after treatment

Exploratory objectives are :

- to study evolution during treatment of neo-angiogenesis measured by dynamic contrast
enhanced-ultrasonography (DCE-US)

- to study the correlation between clinical response and changes of tumor perfusion
measured by DCE-US

Inclusion Criteria:

1. Male or female patients > 18 years of age

2. 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.

3. Locally advanced or locally recurrent inoperable tumor without previous irradiation
[inoperable status must be assessed by staff including a surgeon specialized in

4. No prior treatment by sunitinib malate

5. Life expectancy > 6 months

6. ECOG performance status ≤ 2

7. 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:

- Absolute neutrophil count ≥ 1.,5 G/L

- Platelet count ≥ 100 G/L

- Bilirubin ≤ 1.5 mg/dL

- PT and INR ≤ 1.5 times upper limit of normal [Patients under preventive
anticoagulant therapy are allowed to participate]

- AST and ALT ≤ 2.5 times upper limit of normal

- Creatinine ≤ 150 umol/L

- Calcium ≤ 12 mg/dL

- Blood glucose < 150 mg/dL

8. Fertile patients must use effective contraception prior to, during, and for 28 days
after completion of study therapy

9. Ability to swallow oral medications

10. Mandatory affiliation with a health insurance company

11. Signed written informed consent.

Exclusion Criteria:

1. GIST, Ewing sarcoma or embryonic rhabdomyosarcomas

2. Radiation field including lung, bowel, or central nervous system

3. Pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite

4. NCI grade ≥ 3 hemorrhage within the past 4 weeks prior to study drug administration

5. Significant cardiovascular disease (New York Heart Association (NYHA) > grade 2
congestive cardiac failure, myocardial infarction within 6 months prior to inclusion,
unstable angina, severe cardiac arrhythmia, severe cerebrovascular accident within 6
months prior to inclusion, history of severe thromboembolism (pulmonary embolism or
deep vein thrombosis DVT) within 6 months prior to inclusion (patients with recent
history of DVT treated by anticoagulant (except therapeutic warfarin)during at least
6 weeks are eligibles), prolonged QTc interval (QTc > 480 msec with Bazett),
bradycardia (heart rate < 45bpm), electrolytic troubles (hyponatremia<120mmol/l,
kalemia≥6mmol/l) or uncontrolled hypertension while receiving appropriate medication
(≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic).

6. Less than 6 weeks between prior neoplastic treatment by tyrosine kinase inhibitor and
inclusion and less than 4 weeks for other neoplastic treatments

7. Major surgical procedure, open biopsy, or serious non healing wound within 28 days
prior to first day of treatment

8. Concurrent participation in another clinical trial

9. 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

10. Known brain metastases, spinal cord compression, or carcinomatous meningitis, or
evidence of symptomatic brain or leptomeningeal disease

11. peritoneal carcinosis

12. number of metastatic sites > 2

13. Restriction of freedom by judicial or administrative decision

14. Pregnant or lactating women

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

within 14 weeks after the start of treatment

Safety Issue:


Principal Investigator

Jean Yves Blay, PR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Léon Bérard, Lyon


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2011

Completion Date:

March 2015

Related Keywords:

  • Non GIST Sarcomas
  • non GIST sarcomas
  • sunitinib
  • radiotherapy
  • dose escalation
  • Sarcoma