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

NCT01122615

Last updated date
Study Location
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Cancer, Kidney Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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 2.5 g/dL; f) Serum creatinine

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Renal Cell Cancer, Kidney CancerSunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)
NCT01122615
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)
Official Title  ICMJE Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer
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.
Detailed Description

The Study Drugs:

Sunitinib is designed to block pathways that control important events (such as the growth of blood vessels) that are essential for the growth of cancer.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of sunitinib and temsirolimus based on when you joined this study. There will be 2 stages in this study.

Up to 5 dose levels of the study drug combination will be tested in Stage 1. Two (2) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.

During Stage 2, different doses of the individual study drugs will be tested based on the highest tolerable combination dose that was found in Stage 1.

Study Drug Administration:

During each 3-week "study cycle," you will take sunitinib 1 time each day (either with or without food) for 2 weeks followed by 1 week of rest with no study drug.

You will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30 minutes before you receive temsirolimus, you will receive Benadryl (diphenhydramine) by vein over 30 minutes to help prevent side effects.

If you have any side effects from any of the drugs, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

Study Visits:

Every week (right before you receive temsirolimus), blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of every cycle:

  • You will have a physical exam, including measurement of your vital signs.
  • You will be asked about any drugs or treatments you may be receiving.
  • Your performance status will be recorded.
  • Blood (about 2 teaspoons) will be drawn for routine tests (in addition to the weekly blood draw described above).

Every 6 weeks,:

  • You will have the same imaging scans (CT and/or MRI scan) that you had at the screening visit. If you have stable disease after 2 scans, you will have these every 12 weeks.
  • Blood (about 2 teaspoons) will be drawn to check your thyroid function.
  • Urine will be collected for routine tests.

Blood Pressure Monitoring:

During the first 3 weeks of the study, your blood pressure will be checked weekly. This may be done at your local doctor's office. You should write down your blood pressure each time it is checked in a blood pressure journal that the study staff will give you and bring it with you when you see your doctor.

Length of Study:

You will remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or if you have intolerable side effects.

End-of-Study Visit:

After the last dose of study drug, you will have an end-of-study visit. At the end-of-study visit, the following tests and procedures will be performed:

  • You will have a physical exam, including measurement of your vital signs.
  • You will be asked about any drugs or treatments you may be receiving.
  • You will be asked about any side effects you may have experienced since your last visit.

This is an investigational study. Sunitinib and temsirolimus are both FDA approved and commercially available for the treatment of advanced kidney cancer. The use of the drugs in combination is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Cancer
  • Kidney Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Sunitinib
  • Drug: Temsirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2014)
23
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2010)
60
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01122615
Other Study ID Numbers  ICMJE 2009-0037
NCI-2011-02066 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Nizar M. Tannir, MDUT MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP