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

Phase 2

Completed

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

Interventions: Drug: Doxorubicin
Drug: Gemcitabine
Drug: G-CSF (granulocyte-colony stimulating factor)
Drug: Neulasta

Registration Number: NCT00068393

Lead Sponsor: Eastern Cooperative Oncology Group

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doxorubicin/Gemcitabine	Neulasta	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.
Doxorubicin/Gemcitabine	G-CSF (granulocyte-colony stimulating factor)	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.
Doxorubicin/Gemcitabine	Doxorubicin	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.
Doxorubicin/Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Response Rate by Solid Tumor Response Criteria (RECIST)	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	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

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	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	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.
Overall Survival	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	Overall survival is defined as the time from study entry until death from any cause.

Trial Locations

Locations (91): USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸
Los Angeles, California, United States
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
Scroll for more (81 remaining)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States