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Kidney CancerPhase 2NCT01164228

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

A Phase 2 study testing Gemcitabine and Sunitinib in people with Kidney Cancer, run by ECOG-ACRIN Cancer Research Group at 99 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
Gemcitabine and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
99 sitesUnited States
Study dates
17 Sep 2010to 3 Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed* renal cell carcinoma of any subtype containing any 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
  • 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
  • More than 2 weeks since prior radiotherapy and recovered
  • Previously irradiated lesions must not be the sole site of disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Show all 18Show fewer
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Serum creatinine clearance ≥ 30 mL/min
  • serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal (ULN; ≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Baseline corrected QT interval < 500 msec on EKG
  • Able to swallow pills
  • Negative pregnancy test
  • Fertile patients must use effective contraception before and during study treatment
  • 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
  • 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

Who cannot join

  • Collecting duct or medullary carcinoma
  • Prior systemic therapy for metastatic disease. One prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mtor inhibitor is allowed. Patients who were randomized to placebo on an adjuvant study are eligible
  • History of stroke within the past 6 months.
  • Pregnant or nursing
  • Clinically significant cardiovascular disease, defined as one of the following:
  • Uncontrolled hypertension (blood pressure > 150/100 mm Hg at the time of enrollment); patients with hypertension and BP ≤ 150/100 mm Hg on stable antihypertensive regimen are eligible
Show all 15Show fewer
  • History of myocardial infarction or unstable angina within the past 24 weeks
  • New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
  • Peripheral vascular disease ≥ grade II
  • Ongoing ventricular cardiac dysrhythmias ≥ grade 2 as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
  • History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
  • Ongoing atrial fibrillation
  • Pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained at less than or within the normal range with medication
  • Serious concurrent illness or active infection that would jeopardize the ability of the patient to receive study treatment
  • Known HIV

Trial locations and contacts

99 sites in 1 country.

99 sites in 1 country

United States99 sites

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • Kellogg Cancer Care Center

    Highland Park, Illinois, 60035

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Provena St. Mary's Regional Cancer Center - Kankakee

    Kankakee, Illinois, 60901

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Cancer Center of Kansas, PA - McPherson

    McPherson, Kansas, 67460

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Stanford Cancer Center

    Stanford, California, 94305-5824

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

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.

Read the 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 A: 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 B: 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.

ACTUAL ACCRUAL: A total of 87 patients (47 in arm A and 40 in arm B) were accrued to this study.

Conditions
Kidney Cancer
Being tested
Gemcitabine, Sunitinib
Keywords
recurrent renal cell cancer, stage IV renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma, clear cell sarcoma of the kidney
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called 2'-Deoxy-2', 2'-difluorocytidine monohydrochloride, Gemzar

    Given IV

  • SunitinibDrug

    Also called SU011248 L-Malate salt, SU010398, PHA-290940AD, Sutent

    Given PO

Study groups in NCT01164228
Study groupRoleWhat they receive
Arm A (Sunitinib + Gemcitabine)ExperimentalPatients 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. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Receives: Drug: Gemcitabine; Drug: Sunitinib
Arm B (Sunitinib)ExperimentalPatients receive oral sunitinib malate once daily on days 1-14 and 22-35. Each cycle was 42 days (6 weeks) and was to be repeated for a total of one year.
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Response

    Response is defined as either complete response (CR, disappearance of all lesions) or partial response (PR, at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters, or persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits).

    Measured: Assessed every 3 months for 2 years and every 6 months for year 3.

Secondary outcomes (2)

  1. Progression-free Survival

    Progression-free survival is defined as the time from randomization to progression or death, whichever occurs first. Progression is defined as follows:

    • At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
    • Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Assessed every 3 months for 2 years and every 6 months for year 3.

  2. Overall Survival

    Overall survival is defined as the time from randomization to death or date last known alive.

    Measured: Assessed every 3 months for 2 years and every 6 months for year 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study start17 Sep 2010
  3. Primary completion30 Mar 2020
  4. Study completion3 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164228
Sponsor's protocol ID
E1808
Other IDs
NCT01164228, NCI-2011-02055, U10CA021115
Status last verified
Jun 2023
First submitted
15 Jul 2010
Last updated
15 Jun 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Publications

  • Carthon BC, Kim SE, McDermott DF, Dutcher JP, Puligandla M, Manola J, Pins M, Carducci MA, Plimack ER, Appleman LJ, MacVicar GR, Kohli M, Kuzel TM, DiPaola RS, Haas NB. Results From a Randomized Phase II Trial of Sunitinib and Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features: ECOG-ACRIN E1808. Clin Genitourin Cancer. 2023 Oct;21(5):546-554. doi: 10.1016/j.clgc.2023.06.012. Epub 2023 Jul 3.

    PubMed 37455214

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Sunitinib in people with Kidney Cancer, run by ECOG-ACRIN Cancer Research Group at 99 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Response (time frame: Assessed every 3 months for 2 years and every 6 months for year 3.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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