Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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).

Further Study Information

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 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 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.

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

Eligibility 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• 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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Naomi S. Balzer-Haas

Study Chair

Janice P. Dutcher

Study Chair

Elisabeth I. Heath

Study Chair

Matthew I. Milowsky

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00068393
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top