Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer (NCT00465179) | Clinical Trial Compass
CompletedPhase 2
Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
United States61 participantsStarted 2007-03
Plain-language summary
The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.
Who can participate
SexALL
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Inclusion criteria
✓. Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with conventional-type renal cell carcinoma who have \>/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in fine-needle aspiration (FNA) or core biopsy of any metastatic site are eligible.
✓. Patients must have measurable disease.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
✓. Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin \>/= 9 g/dl, absolute neutrophil count \>/= 1,500/microliter (microL), platelets \>/= 100,000/microL, total bilirubin \</= 1.5 mg/dl, AST(SGOT) and/or ALT (SGPT) \</= 2.5 X institutional uln, except in known hepatic metastasis, wherein may be \</= 5 x uln, serum creatinine \</= 4 X uln (as long as patient does not require dialysis).
✓. Patients must have recovered from any effects of surgery.
✓. Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.
✓. Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study (barrier method, hormonal methods, etc.).
✓. Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.
Exclusion criteria
✕. No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
✕. Pregnant or lactating women are excluded.
✕. Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates. Patients are permitted to receive hematopoietic growth factors according to American Society of Clinical Oncology (ASCO) guidelines.
✕. Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed at least 2 weeks prior to enrollment on this study.
✕. Patients may not have any significant medical disease (other than the malignancy) that, in the investigator's opinion, would increase the risk for participation. Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias requiring medication (subjects with controlled chronic atrial fibrillation are eligible), myocardial infarction within 6 months, uncontrolled HTN (blood pressure \>150/90 on therapy), corrected QT interval (QTc) interval \> 500msec or other significant ECG abnormalities or uncontrolled DM.
✕. Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
✕. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.
What they're measuring
1
Number of Participants With Response to Treatment
Timeframe: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
2
Median Progression-Free Survival (PFS)
Timeframe: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years