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Trial record 17 of 28 for:    kidney cancer, renal cell carcinoma | Recruiting Studies | United States, Florida | Child, Adult, Senior | Phase 1, 2, 3, 4 | NIH, U.S. Fed, Industry, Other

Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery

This study is currently recruiting participants.
Verified December 2012 by Eastern Cooperative Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01164228
First Posted: July 16, 2010
Last Update Posted: July 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  Purpose

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth or tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sunitinib malate and gemcitabine hydrochloride together is more effective than sunitinib malate alone in treating patients with kidney cancer.

PURPOSE: This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery.


Condition Intervention Phase
Kidney Cancer Drug: gemcitabine hydrochloride Drug: sunitinib malate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • Progression-free survival
  • Overall survival
  • Safety

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35.
Drug: gemcitabine hydrochloride
Given IV
Drug: sunitinib malate
Given
Active Comparator: Arm II
Patients receive oral sunitinib malate once daily on days 1-14 and 22-35.
Drug: sunitinib malate
Given

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features.

Secondary

  • To evaluate progression-free survival of these patients.
  • To evaluate overall survival of these patients.
  • To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [clear cell and < 20% sarcomatoid and performance status (PS) 0] vs intermediate risk [20-50% sarcomatoid and PS 0] vs poor risk [non-clear cell or > 50% sarcomatoid or PS 1 or non-clear cell]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35.
  • Arm II: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35.

In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed* renal cell carcinoma

    • Disease of any subtype allowed
    • Disease must have sarcomatoid features NOTE: *Patients must have a paraffin-embedded tumor specimen from the kidney or metastatic site available for central review and confirmation of tumor histology
  • No collecting duct or medullary carcinoma
  • Measurable advanced disease that is not resectable by surgery
  • Patients with resected or radiated brain metastases or those treated with stereotactic radiation therapy are eligible, provided they have been off steroids for at least 2 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • AGC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Serum creatinine clearance ≥ 30 mL/min
  • SGOT and SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Baseline QTc interval < 500 msec on EKG
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before and during study treatment
  • Able to swallow pills
  • No history of stroke within the past 6 months
  • No clinically significant cardiovascular disease, defined as one of the following:

    • Uncontrolled hypertension (BP > 150/100 mm Hg at the time of enrollment)

      • Patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
    • History of myocardial infarction or unstable angina within the past 24 weeks
    • NYHA class II-IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris
    • Peripheral vascular disease ≥ grade II
  • No ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by NCI CTCAE version 4

    • No patients with a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
    • No patients with ongoing atrial fibrillation
  • No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
  • No serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
  • No known HIV
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been disease free for the time period considered appropriate to not interfere with the outcome of this study

PRIOR CONCURRENT THERAPY:

  • No prior systemic therapy for metastatic disease

    • Patients who were randomized to placebo on an adjuvant study are eligible
  • More than 2 weeks since prior radiotherapy and recovered

    • Previously irradiated lesions must not be the sole site of disease
  • More than 2 weeks since prior and no concurrent ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice

    • Topical and inhaled steroids are allowed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164228


  Show 99 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Naomi S. Balzer-Haas, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01164228     History of Changes
Other Study ID Numbers: CDR0000681614
ECOG-E1808
First Submitted: July 15, 2010
First Posted: July 16, 2010
Last Update Posted: July 25, 2014
Last Verified: December 2012

Keywords provided by Eastern Cooperative Oncology Group:
recurrent renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
papillary renal cell carcinoma
clear cell sarcoma of the kidney

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Adenocarcinoma
Urologic Diseases
Gemcitabine
Sunitinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors