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AzTrials

Metastatic Renal Cell CarcinomaPhase 2NCT00068393

Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

A Phase 2 study testing Doxorubicin, Gemcitabine and G-CSF (granulocyte-colony stimulating factor) in people with Metastatic Renal Cell Carcinoma and Renal Cell Carcinoma With Sarcomatoid Features, run by Eastern Cooperative Oncology Group at 92 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: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Doxorubicin, Gemcitabine and G-CSF (granulocyte-colony stimulating factor)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
92 sitesUnited States
Study dates
24 Feb 2004to May 2011
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
  • Features must be of sarcomatoid histology
  • Locally recurrent or metastatic disease not amenable to resection
  • Measurable disease
  • Must have a prior nephrectomy provided all other eligibility criteria are met, and adequately recovered from any recent surgery
  • At least 4 weeks since prior radiotherapy and recovered
Show all 18Show fewer
  • ECOG performance status of 0-1
  • WBC greater than 3,000/mm^3 or absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Bilirubin less than 1.5 mg/dL
  • Aspartate aminotransferase (AST) less than 2 times upper limit of normal
  • Creatinine no greater than 2.0 mg/dL
  • LVEF at least lower limit of normal by MUGA
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer
  • Age of 18 and over
  • Diagnostic material from the kidney or metastatic site biopsy available for central pathologic review

Who cannot join

  • Prior treatment for advanced disease
  • Previously irradiated lesions as the sole site of disease for patients with prior radiation therapy
  • Concurrent local radiotherapy for pain control or for life-threatening situations
  • Myocardial infarction within the past year
  • Congestive heart failure within the past year
  • Significant ischemic or valvular heart disease within the past year
Show all 10Show fewer
  • Prior or concurrent brain metastases
  • Concurrent serious medical illness that would preclude study treatment
  • Active infection that would preclude study treatment
  • Pregnant or nursing

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • 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

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • St. James Community Hospital

    Butte, Montana, 59701

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Hematology and Oncology Associates

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • Mercy Hospital and Medical Center

    Chicago, Illinois, 60616

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

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

    Grosse Pointe Woods, Michigan, 48236

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • William N. Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Foote Hospital

    Jackson, Michigan, 49201

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Howard Community Hospital at Howard Regional Health System

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Central Pennsylvania Hematology and Medical Oncology Associates, PC

    Lemoyne, Pennsylvania, 17043

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • North Shore Oncology and Hematology Associates, Limited - Libertyville

    Libertyville, Illinois, 60048

  • St. Rita's Medical Center

    Lima, Ohio, 45801

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53201-0342

  • Medical Consultants, Limited

    Milwaukee, Wisconsin, 53215

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Cancer Care and Hematology Specialists of Chicagoland - Niles

    Niles, Illinois, 60714

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Hematology Oncology Associates - Skokie

    Skokie, Illinois, 60076

  • Hematology/Oncology of the North Shore at Gross Point Medical Center

    Skokie, Illinois, 60076

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • St. John Macomb Hospital

    Warren, Michigan, 48093

Other trials in United States

About this study

Official title: Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine.
  • Determine the progression-free survival and overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin intravenously (IV) and gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 2- or 3-10 or pegfilgrastim SC on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After 6 courses, patients undergo a MUGA scan. Patients with a stable* left ventricular ejection fraction (LVEF) continue therapy as above. Patients who reach a total doxorubicin dose of 450 mg/m^2 and are found to have unstable cardiac function or who have an abnormal LVEF continue therapy with gemcitabine alone.

NOTE: *Stable cardiac function is defined as no decrease more than 15% of LVEF in absolute number and LVEF at least 35% in total function by MUGA.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 39 patients were accrued for this study.

Being tested
Doxorubicin, Gemcitabine, G-CSF (granulocyte-colony stimulating factor), Neulasta
Keywords
Sarcomatoid, Gemcitabine, Doxorubicin, Renal cell cancer, Kidney cancer
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

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

  • DoxorubicinDrug

    Also called Adriamycin, Rubex

    Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.

  • GemcitabineDrug

    Doxorubicin: 50 mg/m² IV slow push followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Cycles repeat every 2 weeks.

  • G-CSF (granulocyte-colony stimulating factor)Drug

    Also called Neupogen, Filgrastim

    Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.

  • NeulastaDrug

    Also called pegfilgrastim

    Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life.

Study groups in NCT00068393
Study groupRoleWhat they receive
Doxorubicin/GemcitabineExperimentalDoxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.
Receives: Drug: Doxorubicin; Drug: Gemcitabine; Drug: G-CSF (granulocyte-colony stimulating factor); Drug: Neulasta

What is being measured

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

  1. Response Rate by Solid Tumor Response Criteria (RECIST)

    Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

    Measured: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Secondary outcomes (2)

  1. Overall Survival

    Overall survival is defined as the time from study entry until death from any cause.

    Measured: Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

  2. Progression-free Survival

    Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.

    Measured: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry

Timeline

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

  1. First posted11 Sep 2003 (estimated)
  2. Study start24 Feb 2004
  3. Primary completionJun 2009
  4. Study completionMay 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068393
Sponsor's protocol ID
CDR0000322258
Other IDs
E8802, U10CA021115
Status last verified
Jun 2023
First submitted
10 Sep 2003
Last updated
7 Jul 2023
Data monitoring committee
No

Publications

  • Haas N, Manola J, Pins M, et al.: ECOG 8802: phase II trial of doxorubicin (Dox) and gemcitabine (Gem) in metastatic renal cell carcinoma (RCC) with sarcomatoid features. [Abstract] J Clin Oncol 27 (Suppl 15): A-5038, 2009.

  • Haas NB, Lin X, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J. A phase II trial of doxorubicin and gemcitabine in renal cell carcinoma with sarcomatoid features: ECOG 8802. Med Oncol. 2012 Jun;29(2):761-7. doi: 10.1007/s12032-011-9829-8. Epub 2011 Feb 6.

    PubMed 21298497

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin, Gemcitabine and G-CSF (granulocyte-colony stimulating factor) in people with Metastatic Renal Cell Carcinoma and Renal Cell Carcinoma With Sarcomatoid Features, run by Eastern Cooperative Oncology Group at 92 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 10 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 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 4 Jan 2013). 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?

Response Rate by Solid Tumor Response Criteria (RECIST) (time frame: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry). 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 NCT00068393, which also lists 2 linked publications.

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 7 Jul 2023.

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