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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma With Sarcomatoid Features

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Trial Information

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


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.

Inclusion Criteria


INCLUSION CRITERIA:

- 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

- 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

EXCLUSION CRITERIA:

- 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

- Prior or concurrent brain metastases

- Concurrent serious medical illness that would preclude study treatment

- Active infection that would preclude study treatment

- Pregnant or nursing

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate by Solid Tumor Response Criteria (RECIST)

Outcome Description:

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

Outcome 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

Safety Issue:

No

Principal Investigator

Naomi S. Balzer-Haas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000322258

NCT ID:

NCT00068393

Start Date:

December 2003

Completion Date:

May 2011

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal Cell Carcinoma With Sarcomatoid Features
  • Sarcomatoid
  • Gemcitabine
  • Doxorubicin
  • Renal cell cancer
  • Kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
CCOP - Carle Cancer Center Urbana, Illinois  61801
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Foote Hospital Jackson, Michigan  49201
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Duluth Duluth, Minnesota  55805
St. Rita's Medical Center Lima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Great Falls Clinic Great Falls, Montana  59405
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
Hunterdon Regional Cancer Center at Hunterdon Medical Center Flemington, New Jersey  08822
Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
CCOP - Hematology-Oncology Associates of Central New York East Syracuse, New York  13057
Lewistown Hospital Lewistown, Pennsylvania  17044
Mount Nittany Medical Center State College, Pennsylvania  16803
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
St. James Community Hospital Butte, Montana  59701
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Elkhart General Hospital Elkhart, Indiana  46515
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
Mercy Hospital and Medical Center Chicago, Illinois  60616
Hematology and Oncology Associates Chicago, Illinois  60611
Midwest Center for Hematology/Oncology Joliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
Hematology/Oncology of the North Shore at Gross Point Medical Center Skokie, Illinois  60076
Howard Community Hospital at Howard Regional Health System Kokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Miller-Dwan Medical Center Duluth, Minnesota  55805
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles, Illinois  60714
William N. Wishard Memorial Hospital Indianapolis, Indiana  46202
McFarland Clinic, PC Ames, Iowa  50010
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Medical Consultants, Limited Milwaukee, Wisconsin  53215
Aurora Sinai Medical Center Milwaukee, Wisconsin  53201-0342
Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne, Pennsylvania  17043
Billings Clinic Cancer Center Billings, Montana  59107-5100
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045