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Pre-Surgical Sutent in Renal Cell Carcinoma (RCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715442
Recruitment Status : Active, not recruiting
First Posted : July 15, 2008
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Sunitinib Procedure: Nephrectomy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 24, 2008
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Sunitinib + Nephrectomy
Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
Drug: Sunitinib
50 mg by mouth daily for 28 consecutive days
Other Names:
  • SU011248
  • Sunitinib Malate
  • Sutent

Procedure: Nephrectomy
Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.
Other Name: Surgical Removal of Kidney




Primary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: Baseline start of treatment to disease progression; up to 5 years ]
    TTP is defined as the time interval between treatment starts and disease progression or death, whichever occurred first, assessed each cycle (42 days).

  2. Toxicity of Sunitinib in Patients With Metastatic Renal Cell Carcinoma (RCC) [ Time Frame: Start of study drug up to 30 days after study drug stopped ]
    Toxicity defined as any Grade 3 or greater perioperative complications attributable to sunitinib.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. ECOG performance status </= 1.
  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 </= 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
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715442


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
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Principal Investigator: Eric Jonasch, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00715442    
Other Study ID Numbers: 2007-0511
NCI-2012-01678 ( Registry Identifier: NCI CTRP )
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Kidney
Renal Cell Carcinoma
RCC
Sutent
Sunitinib malate
Clear cell
SU011248
Nephrectomy
Surgical removal of kidney
Cytoreductive nephrectomy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action