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

Completed · Phase 2

Conditions studied: Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma With Sarcomatoid Features

In brief

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).

Key facts

Study ID

NCT00068393

Run by

Eastern Cooperative Oncology Group

People needed

39

Starts

2004-02-24

Expected to finish

2011-05-01

Last updated by the study team

2023-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Veterans Affairs Medical Center - Lakeside Chicago — Chicago, Illinois, United States
• Mercy Hospital and Medical Center — Chicago, Illinois, United States
• University of Chicago Cancer Research Center — Chicago, Illinois, United States
• Midwest Center for Hematology/Oncology — Joliet, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• North Shore Oncology and Hematology Associates, Limited - Libertyville — Libertyville, Illinois, United States
• Cancer Care and Hematology Specialists of Chicagoland - Niles — Niles, Illinois, United States
• Hematology Oncology Associates - Skokie — Skokie, Illinois, United States
• Hematology/Oncology of the North Shore at Gross Point Medical Center — Skokie, Illinois, United States
• Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Elkhart General Hospital — Elkhart, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• William N. Wishard Memorial Hospital — Indianapolis, Indiana, United States
• Howard Community Hospital at Howard Regional Health System — Kokomo, Indiana, United States
• Center for Cancer Therapy at LaPorte Hospital and Health Services — La Porte, Indiana, United States
• Saint Anthony Memorial Health Centers — Michigan City, Indiana, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• Saint Joseph Regional Medical Center — South Bend, Indiana, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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