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Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (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. Identifier: NCT01122615
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of the combination of sunitinib and temsirolimus that can be given to patients with metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Kidney Cancer Drug: Sunitinib Drug: Temsirolimus Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer
Study Start Date : May 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Sunitinib + Temsirolimus
Sunitinib 12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle. Temsirolimus 6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
Drug: Sunitinib
12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle.
Other Names:
  • Sunitinib Malate
  • Sutent

Drug: Temsirolimus
6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
Other Names:
  • CCI-779
  • Torisel

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus [ Time Frame: 21 days ]
    Determination of MTD based on the occurrence of dose limiting toxicities (DLTs) during cycle one only after administration of study drugs on day one through day 21. All toxicity graded according to criteria of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 3.0.

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 6 weeks ]
    Response and progression evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the index tumor lesions are used in the RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LDof target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with confirmed metastatic RCC of any histological subtype
  2. Patients must have evaluable disease
  3. Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of these targeted agents in patients < 18 years of age, children will be excluded from this study. RCC in patients < 18 is exceedingly rare in any event.
  4. Eastern Cooperative Oncology Group (ECOG) performance status </= 1
  5. Patients must have adequate organ and marrow function within 14 days as defined below: a) Absolute neutrophil count >/= 1,500/µL; b) Platelet count >/= 100,000/µL; c) Hemoglobin >/= 9.0 g/dL (may be transfused to maintain or exceed this level); d) Total bilirubin </= 2.0 mg/dl; e) Albumin > 2.5 g/dL; f) Serum creatinine </= 2.0 mg/dl; g) AST (SGOT) and ALT (SGPT) </= 2.5 times the institutional upper limit of normal for subjects without evidence of liver metastases; h) AST (SGOT) and ALT (SGPT) </= 5 times the institutional upper limit of normal for subjects with documented liver metastases
  6. Female patients of childbearing potential must have a normal serum beta human chorionic gonadotropin (beta-hCG) within 24 hours prior to beginning treatment on the study due to the possible teratogenic effect.
  7. Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
  8. Patients must give written informed consent prior to initiation of study-related procedures. 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
  9. Patients must be able to swallow pills
  10. Both men and women and members of all races and ethnic groups are eligible for this trial

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 definitively treated and disease free for 2 years. Patients with controlled brain metastases are eligible.
  2. Patients must not be scheduled to receive another anticancer drug while on this study. Patients are permitted to be on concomitant bisphosphonates or megestrol acetate
  3. Patients must not have had a stroke or TIA within 6 months
  4. Patients must not have uncontrolled infections that could be worsened by anticancer therapy or interfere with this study
  5. Patients must not have clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management, or peripheral vascular disease (Grade III or greater)
  6. Patients must not have uncontrolled hypertension, defined as > 140/90 in either systolic or diastolic component (treatment of hypertension with medications is permitted)
  7. Symptomatic peripheral vascular disease
  8. Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breast-feeding should be discontinued if the mother is enrolled on this trial
  9. Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with some of these agents
  10. Patients must not have a clinical history of coagulopathy or bleeding diathesis
  11. Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital) or CYP3A4 inhibitors is not recommended on this study.
  12. Patients with significant baseline proteinuria defined as > grade 2 by screening U/A will be excluded if they have > 2 g protein by urine protein over creatinine (UPC) ratio
  13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  14. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to study enrollment
  15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  16. Non-healing wound, ulcer, or bone fracture
  17. Known hypersensitivity to any component of sunitinib malate, or temsirolimus

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 identifier (NCT number): NCT01122615

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Nizar M. Tannir, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01122615    
Other Study ID Numbers: 2009-0037
NCI-2011-02066 ( Registry Identifier: NCI CTRP )
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: July 2014
Keywords provided by M.D. Anderson Cancer Center:
metastatic renal cell carcinoma
Sunitinib Malate
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors