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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Cancer; Kidney Cancer

Intervention: Sunitinib (Drug); Temsirolimus (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Nizar M. Tannir, MD, Study Chair, Affiliation: UT MD Anderson Cancer Center

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.

Clinical Details

Official title: Phase I Trial of Sunitinib Plus Temsirolimus in Patients With Metastatic Renal Cell Cancer

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus

Secondary outcome: Response Rate

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. Eastern Cooperative Oncology Group (ECOG) performance status /= 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 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

Locations and Contacts

UT MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: May 2010
Last updated: July 9, 2014

Page last updated: August 23, 2015

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