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

NCT01122615 | Completed Phase 1

• 2 other identifiers: 2009-0037NCI-2011-02066
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Cancer; Kidney Cancer

Keywords

Kidney; metastatic renal cell carcinoma; RCC; Sunitinib; Sunitinib Malate; Sutent; Temsirolimus; Torisel

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Sunitinib and Temsirolimus

  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.

  21 days

Secondary Outcomes (1)

• Response Rate

  6 weeks

Study Arms (1)

Sunitinib + Temsirolimus

EXPERIMENTAL

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; Drug: Temsirolimus

Interventions

Sunitinib DRUG

12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle.

Also known as: Sunitinib Malate, Sutent

Sunitinib + Temsirolimus

Temsirolimus DRUG

6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.

Also known as: CCI-779, Torisel

Sunitinib + Temsirolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed metastatic RCC of any histological subtype
• Patients must have evaluable disease
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 1
• 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
• 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.
• Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study
• 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
• Patients must be able to swallow pills
• Both men and women and members of all races and ethnic groups are eligible for this trial

You may not qualify if:

• 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.
• 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
• Patients must not have had a stroke or TIA within 6 months
• Patients must not have uncontrolled infections that could be worsened by anticancer therapy or interfere with this study
• 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)
• Patients must not have uncontrolled hypertension, defined as \> 140/90 in either systolic or diastolic component (treatment of hypertension with medications is permitted)
• Symptomatic peripheral vascular disease
• 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
• 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
• Patients must not have a clinical history of coagulopathy or bleeding diathesis
• 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.
• 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
• 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
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to study enrollment
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Sunitinib; temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nizar M. Tannir, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2014-07

Locations

US (1)