Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01122615
First received: May 11, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Renal Cell Cancer
Kidney Cancer
Drug: Sunitinib
Drug: Temsirolimus
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 week cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122615

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Study Chair: Nizar M. Tannir, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01122615     History of Changes
Other Study ID Numbers: 2009-0037
Study First Received: May 11, 2010
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Kidney
metastatic renal cell carcinoma
RCC
Sunitinib
Sunitinib Malate
Sutent
Temsirolimus
Torisel

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Sunitinib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014