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Renal Cell CarcinomaPhase 2NCT00715442

Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

A Phase 2 study testing Sunitinib and Nephrectomy in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied. Read more about this study

Who is it for?
Any age
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Sunitinib and Nephrectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
24 Jun 2008to 4 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • ECOG performance status </= 1.
  • 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 </= 2.0 mg/dl • serum creatinine </= 1.5 times the upper limit of normal (ULN) e) AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional ULN for subjects without evidence of liver metastases f) AST(SGOT) and/or ALT (SGPT) </= 5 X institutional ULN for subjects with documented liver metastases
  • 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.
  • Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study, i.e. condoms.
  • 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.

Who cannot join

  • Patients must not have organ allografts.
  • 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.
  • 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.
  • Patients must not have received any prior anticancer therapy for renal cell carcinoma. Radiation therapy is allowed if > 2 weeks from study drug administration.
  • 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.
  • 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.
Show all 15Show fewer
  • 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.
  • 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.
  • Patients receiving any concomitant systemic therapy for renal cell cancer are excluded, but patients taking bisphosphonates and megestrol acetate are not excluded.
  • Patients must not require total parenteral nutrition with lipids.
  • Patients must not have clinical history of coagulopathy, bleeding diathesis or thrombosis within the past year.
  • Patients must not have serious, non-healing wound, ulcer, or bone fracture.
  • Pregnancy (positive pregnancy test) or lactation.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  • Know hypersensitivity to any component of sunitinib.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

The goal of this clinical research study is to learn if Sutent® (sunitinib malate), given before surgery, can help control renal cell carcinoma. The safety of sunitinib malate will also be studied.

Read the detailed description

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.

Being tested
Sunitinib, Nephrectomy
Keywords
Kidney, Renal Cell Carcinoma, RCC, Sutent, Sunitinib malate, Clear cell, SU011248, Nephrectomy, Surgical removal of kidney, Cytoreductive nephrectomy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called SU011248, Sunitinib Malate, Sutent

    50 mg by mouth daily for 28 consecutive days

  • NephrectomyProcedure or surgery

    Also called Surgical Removal of Kidney

    Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Study groups in NCT00715442
Study groupRoleWhat they receive
Sunitinib + NephrectomyExperimentalSunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
Receives: Drug: Sunitinib; Procedure: Nephrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression (TTP)

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

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

  2. Toxicity of Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC)

    Toxicity defined as any Grade 3 or greater perioperative complications attributable to sunitinib.

    Measured: Start of study drug up to 30 days after study drug stopped

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2008 (estimated)
  2. Study start24 Jun 2008
  3. Primary completion4 Dec 2026 (estimated)
  4. Study completion4 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00715442
Sponsor's protocol ID
2007-0511
Other IDs
NCI-2012-01678
Status last verified
Jun 2026
First submitted
11 Jul 2008
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361.

    PubMed 36848607

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib and Nephrectomy in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (TTP) (time frame: Baseline start of treatment to disease progression; up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00715442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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