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Phase II Non-Randomized Pre-Surgical Study Evaluating Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) Who Are Eligible for Cytoreductive Nephrectomy


Phase 2
N/A
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma

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Trial Information

Phase II Non-Randomized Pre-Surgical Study Evaluating Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) Who Are Eligible for Cytoreductive Nephrectomy


The Study Drug:

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.

Study Treatment:

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.

During Cycle 2, you will have surgery to remove the tumor. You will start taking sunitinib
malate again after surgery (at least 14 days after surgery) on the same schedule as before.

Study Visits:

At the beginning of each new cycle (Cycles 1-6), you will have the following tests:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs, and weight.

- You will have a performance status evaluation.

- You will be asked about any medicines you are currently taking and if you have
experienced any side effects since your last visit.

- You will have blood drawn (about 4 teaspoons) for routine testing. This blood will also
be tested to check the function of your thyroid gland.

- You will have follow-up scans (the same ones you had during screening to check the
disease status) at the beginning of Cycle 2, after you have surgery, and at the
beginning of each of the next 4 cycles.

- You will have an ECG to measure the health of your heart.

Every 2 Cycles, you will have a follow-up echocardiogram or MUGA scan to check your heart
function, if your doctor feels it is needed.

Beginning in Cycle 7, you will be asked to return to the clinic every other cycle (about
every 12 weeks), unless your doctor thinks you should return more often. This means you
would return for clinic visits at the start of Cycles 8, 10, 12, and so on, and may be asked
to come back at other times.

At each visit, you will have the following tests:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs and weight.

- You will have a performance status evaluation.

- You will be asked about any medicines you are currently taking and if you have
experienced any side effects since your last visit.

- You will have blood drawn (about 4 teaspoons) for routine testing at the beginning of
each cycle. If you are scheduled to return to M. D. Anderson every 2 cycles (12
weeks), you may have the blood drawn for routine tests at your local doctor's office
during the "non-visit" cycles.

- You will have an ECG to measure the health of your heart.

- You will have an echocardiogram or MUGA scan to check your heart function, if your
doctor feels it is needed.

- You will have follow-up scans (the same ones you had during screening to check the
disease status).

Length of Study:

You will continue taking sunitinib malate on this study, unless the disease gets worse, you
experience intolerable side effects, and/or you need an alternative treatment during the
course of the study.

Early Withdrawal:

Early withdrawal is defined as a patient not being able to complete a full cycle of
sunitinib malate. If you withdraw early, you will return to clinic for the following tests:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs, and weight.

- You will have a performance status evaluation.

- You will have blood drawn (about 4 teaspoons) and urine collected for routine testing.
This blood will also be tested to check the function of your thyroid gland.

- You will have an ECG to measure the health of your heart.

- You will be asked about any medicines you are currently taking and if you have
experienced any side effects since your last visit.

- You will have follow-up scans (the same ones you had during screening to check the
disease status).

Post Treatment Evaluation (within 1 month of the last dose):

About 30 days after your last dose of sunitinib malate, you will return to the clinic for a
follow-up visit. You will have the following tests:

- Your complete medical history will be recorded.

- You will have a physical exam, including measurement of your vital signs, and weight.

- You will have a performance status evaluation.

- You will have blood drawn (about 4 teaspoons) and urine collected for routine testing.
This blood will also be tested to check the function of your thyroid gland.

- You will be asked about any medicines you are currently taking and if you have
experienced any side effects since your last visit.

- You will have follow-up scans (the same as at screening) to check the status of the
disease.

- You will have an ECG to measure the health of your heart.

Long-Term Follow-Up:

Following the post-treatment visit, you will be contacted regularly to check the status of
the disease. You will be contacted (by telephone or routine clinic visit) every 6-12 weeks
for the first 2 years, and every 6 months after that for up to 5 years.

This is an investigational study. Sunitinib malate is commercially available and FDA
approved for treatment of clear-cell renal cell carcinoma. At this time, its use in
combination with surgery is for research only. Up to 50 patients will take part in this
study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Patients with histologically or cytologically confirmed metastatic clear cell RCC who
are eligible for cytoreductive nephrectomy. The determination of resectability will
ultimately lie in the clinical judgment of the urologist and medical oncologist
involved in the care of the patient.

2. Measurable disease is defined as a lesion that can be accurately measured in at least
one dimension (longest diameter to be recorded) and measures >/= 20 mm with
conventional techniques or >/= 10 mm with spiral CT scan. This does not include
primary tumors, which will be removed.

3. Eastern Cooperative Oncology Group (ECOG) performance status
4. Patients must have adequate organ and marrow function within 14 days as defined
below: a) absolute neutrophil count >/= 1,500/microL b) platelets >/= 75,000/microL
c) Hgb > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g., Epogen®] to
maintain this level) d) total bilirubin times the upper limit of normal (ULN) e) AST(SGOT) and/or ALT (SGPT) institutional ULN for subjects without evidence of liver metastases f) aspartate
aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) institutional ULN for subjects with documented liver metastases

5. Female patients of childbearing potential (i.e. premenopausal, no hysterectomy) must
have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours
prior to enrolling in the study due to the possible teratogenic effect. Patients with
an elevated betaHCG will undergo appropriate evaluation to rule out pregnancy (i.e.
referral to Gyn service, pelvic ultrasound) and if pregnancy is ruled out and
elevated betaHCG is determined to be of tumor origin, patients will be permitted to
proceed on study.

6. Patients of child fathering or childbearing potential must agree to practice a form
of medically acceptable birth control while on study, i.e. condoms.

7. 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 able to fully understand the investigational
nature of the study and the risks associated with the therapy. The only approved
consent is attached to this protocol.

Exclusion Criteria:

1. Patients must not have organ allografts.

2. Patients must not have had major surgical procedure, open biopsy, or significant
traumatic injury within 14 days prior to Day 0, or anticipation of need for major
surgical procedure during the course of the study (other than defined by protocol);
or fine needle aspirations or core biopsies within 7 days prior to Day 0.

3. 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.

4. Patients must not have received any prior anticancer therapy for renal cell
carcinoma. Radiation therapy is allowed if > 2 weeks from study drug administration.

5. Patients must not be scheduled to receive another experimental drug while on this
study. Patients are permitted to be on concomitant bisphosphonates and megestrol
acetate.

6. Patients must not have a primary brain tumor (excluding meningiomas other benign
lesions), any brain metastases, leptomeningeal disease, seizure disorders not
controlled with standard medical therapy, history of stroke within the past year.

7. History of serious systemic disease, including myocardial infarction or unstable
angina within the last 12 months, history of hypertensive crisis or hypertensive
encephalopathy, uncontrolled hypertension (blood pressure of > 140/90 mmHg) at the
time of enrollment, New York Heart Association (NYHA) Grade II or greater congestive
heart failure, unstable symptomatic arrhythmia requiring medication (subjects with
chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular
tachycardia are eligible), significant vascular disease or symptomatic peripheral
vascular disease.

8. 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 an investigational drug or that
might affect the interpretation of the results of the study or render the subject at
high risk from treatment complications.

9. Patients receiving any concomitant systemic therapy for renal cell cancer are
excluded, but patients taking bisphosphonates and megestrol acetate are not excluded.

10. Patients must not require total parenteral nutrition with lipids.

11. Patients must not have clinical history of coagulopathy, bleeding diathesis or
thrombosis within the past year.

12. Patients must not have serious, non-healing wound, ulcer, or bone fracture.

13. Pregnancy (positive pregnancy test) or lactation.

14. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment.

15. Know hypersensitivity to any component of sunitinib.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to progression (TTP)

Outcome Description:

TTP is defined as the time interval between treatment starts and disease progression or death, whichever occurred first, assessed each cycle (42 days).

Outcome Time Frame:

Baseline start of treatment to disease progression; up to 5 years

Safety Issue:

No

Principal Investigator

Eric Jonasch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2007-0511

NCT ID:

NCT00715442

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney
  • Renal Cell Carcinoma
  • RCC
  • Sutent
  • Sunitinib malate
  • Clear cell
  • SU011248
  • Nephrectomy
  • Surgical removal of kidney
  • Cytoreductive nephrectomy
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030