Clinical trial NCT00465179: Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
Official title: Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Kidney Cancer
Keywords: Non-Clear Cell Renal Carcinoma
Non-clear cell renal cell cancer
Renal Cell Cancer
Kidney Cancer
Papillary
Chromophobe
Collecting duct carcinoma
CDC
Renal medullary carcinoma
RMC
Sunitinib Malate
Sutent
SU011248
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-04-24
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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 \</= 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).
5. Patients must have recovered from any effects of surgery.
6. 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.
7. 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.).
8. 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.
9. Patients with brain metastases may participate in this trial.
10. Patients who have had up to two prior systemic therapies are eligible to participate in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such as sorafenib or sunitinib malate.

Exclusion Criteria:

1. 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.
2. Pregnant or lactating women are excluded.
3. 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.
4. 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.
5. 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.
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.

Primary outcomes:
measure: Number of Participants With Response to Treatment
timeFrame: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
measure: Median Progression-Free Survival (PFS)
timeFrame: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
Secondary outcomes:
measure: Median Overall Survival
timeFrame: Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nizar M. Tannir, MD
role: PRINCIPAL_INVESTIGATOR
References: