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Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01392183
First received: July 8, 2011
Last updated: December 22, 2016
Last verified: December 2016
  Purpose

The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied.

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.

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


Condition Intervention Phase
Kidney Cancer Drug: Pazopanib Drug: Temsirolimus Behavioral: Quality of Life Assessment Drug: Benadryl Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial of Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Assessments every 8 weeks from baseline to 1 year. ]
    PFS is the time from initiation of treatment to time of first disease progression/death due to any cause. Repeat radiological studies (Computed Tomography, Magnetic Resonance Imaging as indicated) to evaluate response every 8 weeks. Time to event endpoints summarized using Kaplan-Meier.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Assessments every 8 weeks from baseline to 1 year. ]
    Overall survival is calculated from day of therapy initiation to the date of death. Kaplan-Meier estimator used to estimate the OS for each group of participants.


Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib
Pazopanib 800 mg by mouth daily. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.
Drug: Pazopanib
800 mg by mouth daily in 4 week study cycle.
Other Name: GW786034
Behavioral: Quality of Life Assessment
Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.
Other Names:
  • Questionnaires
  • Surveys
Experimental: Temsirolimus
Temsirolimus 25 mg by vein infused over 30-60 minutes weekly. Benadryl 25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.
Drug: Temsirolimus
25 mg by vein infused over 30-60 minutes every week in 4 week study cycle.
Other Names:
  • CCI-779
  • Torisel
Behavioral: Quality of Life Assessment
Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.
Other Names:
  • Questionnaires
  • Surveys
Drug: Benadryl
25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.
Other Name: Diphenhydramine

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Pathologic confirmation of metastatic or locally advanced RCC with a major clear cell component.
  2. Measurable disease by RECIST criteria.
  3. Age >/= 18 years
  4. ECOG performance status 0-2 or Karnofsky Performance Status >/= 60%
  5. Meets criteria for poor-risk defined as 3 or more of the following: ECOG performance status 2, anemia (hemoglobin lower than reference range), elevated serum LDH > 1.5x upper limit of normal (ULN), hypercalcemia (corrected serum calcium level > upper limit of normal), time from initial RCC diagnosis to registration on this trial < 1 year, and > 1 metastatic organ sites.
  6. Adequate organ and marrow function within 14 days of registration as defined below: a) Absolute neutrophil count >/=1,500/µL b) Platelets >/=100,000/µL c) Hgb >/= 9.0 g/dL (transfusion allowed) d) Renal: serum creatinine </= 1.5 x ULN or calculated CrCl >/= 40 cc/min and random urine protein:creatinine ratio (UPC) < 1 or 24-hr urine protein < 1g e) Liver: total bilirubin </= 1.5 mg/dl; AST (SGOT) and ALT (SGPT) </= 2.5 x ULN for subjects without evidence of liver metastases, </= 5 x ULN for subjects with documented liver metastases f) INR </= 1.2 x ULN; PTT </= 1.5 x ULN. Therapeutic anticoagulation with warfarin is allowed if target INR </= 3 on a stable dose of warfarin or on a stable dose of LMW heparin for > 2 weeks (14 days) at time of randomization.
  7. Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test within 14 days of study registration. Pregnancy test must be repeated if performed > 14 days before starting study drug.

Exclusion Criteria:

  1. Prior malignancy, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years
  2. Prior targeted therapy (anti-VEGF agents or mTOR inhibitors) including adjuvant therapy, and prior chemotherapy for mRCC. However, prior immunotherapy (cytokines or vaccines) is allowed.
  3. Any experimental drug while on this study; however, concomitant bone targeted therapy (bisphosphonates or the anti-RANK ligand denosumab) is allowed.
  4. Uncontrolled brain metastases and infections. Patients with brain metastases treated with Gamma Knife (GK) or whole brain radiation within 24 hours of registration.
  5. History of stroke within 6 months of registration
  6. Clinically significant cardiovascular disease, defined as myocardial infarction (or unstable angina) within 6 months of registration, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia refractory to medical management. However, treated and controlled or stable/not clinically significant cardiovascular disease is allowed per evaluation by cardiologist.
  7. Uncontrolled hypertension (home blood pressure readings are permitted) or prior history of hypertensive crisis or hypertensive encephalopathy; however, treatment of hypertension with medications is permitted.
  8. History of uncontrolled hemoptysis (>/= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  9. Significant vascular disease including aortic aneurysm, aortic dissection.
  10. Symptomatic peripheral vascular disease
  11. Pregnancy
  12. HIV-positive patients receiving combination anti-retroviral therapy
  13. Coagulopathy or bleeding diathesis
  14. Concomitant treatment with rifampin, St. John's wort, or the cytochrome p450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital)
  15. Major surgery within 28 days prior to registration
  16. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device within 7 days prior to starting drug
  17. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration
  18. Serious non-healing wound
  19. Baseline QTcB >/= 470 msec.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392183

Contacts
Contact: Amado Zurita, MD 713-792-2830

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis
Investigators
Principal Investigator: Amado Zurita, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01392183     History of Changes
Other Study ID Numbers: 2011-0358
NCI-2011-01277 ( Registry Identifier: NCI CTRP )
Study First Received: July 8, 2011
Last Updated: December 22, 2016

Keywords provided by M.D. Anderson Cancer Center:
Kidney cancer
Renal Cell Carcinoma
Poor-Risk Clear-Cell Renal Cell Carcinoma
RCC
Metastatic
Locally advanced
Complete response
CR
Partial Response
PR
Overall survival
OS
Time to progression
TTP
Pazopanib
GW786034
Temsirolimus
CCI-779
Torisel
Benadryl
Diphenhydramine
TemPa

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Diphenhydramine
Promethazine
Everolimus
Sirolimus
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017