Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma
Overview[ - collapse ][ - ]
| Purpose | 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). |
|---|---|
| Condition | Metastatic Renal Cell Carcinoma Renal Cell Carcinoma With Sarcomatoid Features |
| Intervention | Drug: Doxorubicin Drug: Gemcitabine Drug: G-CSF (granulocyte-colony stimulating factor) Drug: Neulasta |
| Phase | Phase 2 |
| Sponsor | Eastern Cooperative Oncology Group |
| Responsible Party | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier | NCT00068393 |
| First Received | September 10, 2003 |
| Last Updated | January 4, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 10, 2003 |
|---|---|
| Last Updated Date | January 4, 2013 |
| Start Date | December 2003 |
| Estimated Primary Completion Date | May 2011 |
| Current Primary Outcome Measures | 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] [Designated as safety issue: No]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 |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma |
|---|---|
| Official Title | Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features |
| Brief 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. 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). |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Doxorubicin 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. Other Names:
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. Drug: G-CSF (granulocyte-colony stimulating factor) 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. Other Names:
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. Other Names: pegfilgrastim |
| Study Arm (s) | Experimental: Doxorubicin/Gemcitabine Doxorubicin 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 39 |
| Estimated Completion Date | May 2011 |
| Estimated Primary Completion Date | June 2009 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00068393 |
|---|---|
| Other Study ID Numbers | CDR0000322258 |
| Has Data Monitoring Committee | No |
| Information Provided By | Eastern Cooperative Oncology Group |
| Study Sponsor | Eastern Cooperative Oncology Group |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Study Chair: Naomi S. Balzer-Haas, MD Fox Chase Cancer Center |
| Verification Date | January 2013 |
Locations[ + expand ][ + ]
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, United States, 90089-9181 |
|---|---|
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado, United States, 80045 |
| Rush-Copley Cancer Care Center | Aurora, Illinois, United States, 60507 |
| University of Chicago Cancer Research Center | Chicago, Illinois, United States, 60637-1470 |
| Mercy Hospital and Medical Center | Chicago, Illinois, United States, 60616 |
| Hematology and Oncology Associates | Chicago, Illinois, United States, 60611 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois, United States, 60611-3013 |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois, United States, 60611 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois, United States, 60435 |
| Midwest Center for Hematology/Oncology | Joliet, Illinois, United States, 60432 |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois, United States, 60048 |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois, United States, 60714 |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie, Illinois, United States, 60076 |
| Hematology Oncology Associates - Skokie | Skokie, Illinois, United States, 60076 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois, United States, 61801 |
| CCOP - Carle Cancer Center | Urbana, Illinois, United States, 61801 |
| Elkhart General Hospital | Elkhart, Indiana, United States, 46515 |
| Indiana University Cancer Center | Indianapolis, Indiana, United States, 46202-5289 |
| William N. Wishard Memorial Hospital | Indianapolis, Indiana, United States, 46202 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana, United States, 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana, United States, 46350 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana, United States, 46360 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana, United States, 46601 |
| Memorial Hospital of South Bend | South Bend, Indiana, United States, 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana, United States, 46617 |
| McFarland Clinic, PC | Ames, Iowa, United States, 50010 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa, United States, 52403 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa, United States, 51101 |
| Siouxland Regional Cancer Center | Sioux City, Iowa, United States, 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa, United States, 51104 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States, 02215 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts, United States, 02118 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, United States, 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan, United States, 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan, United States, 48123-2500 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States, 48201-1379 |
| Genesys Hurley Cancer Institute | Flint, Michigan, United States, 48503 |
| Hurley Medical Center | Flint, Michigan, United States, 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan, United States, 48236 |
| Foote Hospital | Jackson, Michigan, United States, 49201 |
| Bronson Methodist Hospital | Kalamazoo, Michigan, United States, 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan, United States, 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan, United States, 49001 |
| Sparrow Regional Cancer Center | Lansing, Michigan, United States, 48909 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan, United States, 48601 |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | St. Joseph, Michigan, United States, 49085 |
| St. John Macomb Hospital | Warren, Michigan, United States, 48093 |
| CCOP - Duluth | Duluth, Minnesota, United States, 55805 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota, United States, 55805 |
| Miller-Dwan Medical Center | Duluth, Minnesota, United States, 55805 |
| Mayo Clinic Cancer Center | Rochester, Minnesota, United States, 55905 |
| Northern Rockies Radiation Oncology Center | Billings, Montana, United States, 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana, United States, 59101 |
| Billings Clinic Cancer Center | Billings, Montana, United States, 59107-5100 |
| CCOP - Montana Cancer Consortium | Billings, Montana, United States, 59101 |
| St. Vincent Healthcare | Billings, Montana, United States, 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana, United States, 59107-7000 |
| Bozeman Deaconess Cancer Center | Bozeman, Montana, United States, 59715 |
| St. James Community Hospital | Butte, Montana, United States, 59701 |
| Great Falls Clinic | Great Falls, Montana, United States, 59405 |
| United States, Montana | Great Falls, Montana, United States, 59405 |
| St. Peter's Hospital | Helena, Montana, United States, 59601 |
| Kalispell Regional Medical Center | Kalispell, Montana, United States, 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana, United States, 59901 |
| Kalispell Medical Oncology | Kalispell, Montana, United States, 59901 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana, United States, 59807-7877 |
| Guardian Oncology and Center for Wellness | Missoula, Montana, United States, 59804 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana, United States, 59807 |
| Community Medical Center | Missoula, Montana, United States, 59801 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey, United States, 08822 |
| CCOP - Northern New Jersey | Hackensack, New Jersey, United States, 07601 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey, United States, 08903 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York, United States, 10466 |
| Roswell Park Cancer Institute | Buffalo, New York, United States, 14263-0001 |
| CCOP - Hematology-Oncology Associates of Central New York | Syracuse, New York, United States, 13057 |
| St. Rita's Medical Center | Lima, Ohio, United States, 45801 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States, 17033-0850 |
| Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania, United States, 17043 |
| Lewistown Hospital | Lewistown, Pennsylvania, United States, 17044 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania, United States, 19111-2497 |
| Mount Nittany Medical Center | State College, Pennsylvania, United States, 16803 |
| Avera Cancer Institute | Sioux Falls, South Dakota, United States, 57105 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota, United States, 57105 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota, United States, 57117-5039 |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia, United States, 26102 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin, United States, 54601 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin, United States, 53792-6164 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin, United States, 54449 |
| Medical Consultants, Limited | Milwaukee, Wisconsin, United States, 53215 |
| Aurora Sinai Medical Center | Milwaukee, Wisconsin, United States, 53201-0342 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin, United States, 54868 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, United States, 82801 |