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Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Cancer; Kidney Cancer

Intervention: Sunitinib Malate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Nizar M. Tannir, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

Official title: Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma

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

Primary outcome: Clinical Activity [Response rate + Progression free survival (PFS)]

Detailed description: Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment. Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at your local doctor's office. You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1. At this visit, your medical history will be recorded, and your ability to perform daily activities will be evaluated. You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have experienced since your last visit. You will be asked about any medicines you may be currently taking. You will have blood drawn (about 4 teaspoons) for routine testing. Beginning Day 1 of Cycle 3, you will return to clinic every 12 weeks (Day 1 of each cycle). You will have the same evaluations as you did at the Day 29 visit. On Day 1 of every other cycle, you will have an ECG and a doppler echocardiogram or multigated acquisition (MUGA) scan to evaluate your heart health. You will have follow-up imaging scans (CT and/or MRI) to track your response to treatment on Day 1 of the first 2 cycles and every 12 weeks thereafter for as long as you are receiving treatment on this study. You will continue to receive treatment on this study, unless your disease gets worse, you develop an illness that prevents you from continuing treatment, or you experience any intolerable side effects of the study drug. You will be removed from this study if any of these circumstances occur. This is an investigational study. Sunitinib malate has been authorized by the FDA for treatment of clear cell renal carcinoma. Its use in non-clear cell renal carcinoma is experimental. Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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. 2. Patients must have measurable disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. 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 150/90 on therapy), corrected QT interval (QTc) interval > 500msec or other significant ECG abnormalities or uncontrolled DM. 6. 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. 7. Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended. 8. Patients unwilling to participate or unable to comply with the protocol for the duration of the study.

Locations and Contacts

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: March 2007
Last updated: March 18, 2015

Page last updated: August 23, 2015

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