Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Adva… (NCT00499135) | Clinical Trial Compass
CompletedPhase 1
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
United States25 participantsStarted 2007-05-22
Plain-language summary
This phase I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors. Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed renal cell cancer; or other solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which no standard curative therapy exists
* For the renal cell cancer subset, a component of clear cell histology is required
* Measurable disease, defined as \>= 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques or \>= 10 mm by spiral CT scan
* Life expectancy \> 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Leukocytes \>= 3,000/mm\^3
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 9 g/dL
* Serum calcium =\< 12.0 mg/dL
* Total bilirubin normal
* Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times upper limit of normal (ULN), unless subjects have liver metastases, in which case both AST and ALT must be =\< 5 x ULN
* Creatinine =\< 2 times ULN OR creatinine clearance \>= 40 mL/min for patients with creatinine levels above 2 x institutional normal
* All patients need to be willing to undergo planned pharmacodynamic assessments, including serial PET imaging, plasma markers, and pharmacokinetic sampling
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to …
What they're measuring
1
Objective response
Timeframe: Up to 3 years
2
Plasma VEGF and HIF1-alpha levels
Timeframe: Up to 3 years
3
Standard uptake value as measured by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans