Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma (Kidney Cancer)

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-8802 E8802, NCT00068393, SWOG-E8802, CALGB-E8802, RPCI-NCG 85006

Special Category: CTSU trial

Objectives

1. Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine.
2. Determine the progression-free and overall survival of patients treated with this regimen.
3. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed renal cell carcinoma
  • Features must be of sarcomatoid histology
  • Locally recurrent or metastatic disease not amenable to resection



• Measurable disease



• Original diagnostic material available for pathology review



• No prior or concurrent brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered
  • No previously irradiated lesions as the sole site of disease
• No concurrent local radiotherapy for pain control or for life-threatening situations

Surgery

• Prior nephrectomy allowed
• Recovered from prior surgery

Other

• No prior treatment for advanced disease

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm³

  OR

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³

Hepatic

• Bilirubin less than 1.5 mg/dL
• AST less than 2 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past year
• No congestive heart failure within the past year
• No significant ischemic or valvular heart disease within the past year
• LVEF at least lower limit of normal by MUGA

Other

• Not pregnant or nursing
• 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
• No active infection that would preclude study treatment
• No other concurrent serious medical illness that would preclude study treatment

Expected Enrollment

A total of 16-40 patients will be accrued for this study within 1.3-3.3 years.

Outcomes

Response rate
Overall survival
Progression-free survival
Toxicity

Outline

This is a multicenter study.

Patients receive doxorubicin 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/m² 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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Naomi Balzer-Haas, MD, Protocol chair		Ph: 215-728-2974; 888-369-2427
Janice Dutcher, MD, Protocol co-chair		Ph: 718-304-7200

Southwest Oncology Group

Elisabeth Heath, MD, Protocol co-chair		Ph: 313-576-8715; 800-527-6266 Email: heathe@karmanos.org

Cancer and Leukemia Group B

Matthew Milowsky, MD, Protocol chair		Ph: 212-746-6717

Registry Information
Official Title		Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma with Sarcomatoid Features
Trial Start Date		2003-12-09
Registered in ClinicalTrials.gov		NCT00068393
Date Submitted to PDQ		2003-07-18
Information Last Verified		2007-04-19
NCI Grant/Contract Number		CA21115

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