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

Phase 2
18 Years
Not Enrolling
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


- Determine the response rate of patients with locally recurrent or metastatic
unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and

- 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


- 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


- 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:


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:


Principal Investigator

Naomi S. Balzer-Haas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




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



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