Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary R… (NCT00541008) | Clinical Trial Compass
CompletedPhase 2
Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
France92 participantsStarted 2007-09-05
Plain-language summary
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
Inclusion criteria:
* Diagnosis of papillary renal cell carcinoma
* Locally advanced or metastatic disease
* Type I or type II disease
* Progressive disease
* Measurable disease defined by RECIST criteria as at least 1 lesion at least 2 cm in length by conventional CT scan techniques or at least 1 cm by spiral CT scan
* No brain metastases including treated and nonprogressive metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 3 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Serum creatinine \< 1.5 times ULN
* INR ≤ 1.7 or PT ≤ 6 seconds over ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Patients must be affiliated to a Social Security System
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion criteria:
* NCI CTC grade 3 hemorrhage within 4 weeks prior to start of study treatment
* Diagnosis of any second malignancy within the past 3 years except for basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix that has been adequately treated with no evidence of recurrent disease within the past 12 months
* Spinal cord compression, carcinomatous meningitis, or leptomeni…