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Effects of Sunitinib in the Expression of VEGF and of Interleukin 8: Explanation of Anti-angiogenic Effects.


N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Effects of Sunitinib in the Expression of VEGF and of Interleukin 8: Explanation of Anti-angiogenic Effects.


OBJECTIVES:

Primary

- To determine whether a link exists between the effectiveness of therapy with sunitinib
malate and development of blood biomarkers, specifically the angiogenic factors VEGF
and interleukin-8 (IL-8), in patients with kidney cancer.

Secondary

- To evaluate the link between the time to progression and the development of VEGF and
IL-8 blood levels in these patients.

- To evaluate the link between VEGF and IL-8 blood levels and disease-free survival of
these patients after 3, 6, 9, and 12 months of treatment.

- To evaluate the link between VEGF and IL-8 blood levels and overall survival of these
patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks
in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Metastatic disease requiring first-line treatment with sunitinib malate

- No prior therapy for metastatic disease

- No symptomatic or uncontrolled cerebral metastasis

PATIENT CHARACTERISTICS:

- Affiliation to the French Social insurance

- Life expectancy ≥ 3 months

- No heart failure

- No chronic unstable disease

- No long QT interval

- No history of another primary cancer

- No severe, uncontrolled acute infection

- No severe, uncontrolled hypertension

- No psychological disorder

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response

Safety Issue:

No

Principal Investigator

Jean Marc Ferrero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000638415

NCT ID:

NCT00943839

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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