Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens

Kidney Cancer Research Bureau

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Renal Cell

Treatments

Drug: capecitabine, interferon-alpha

Study type

Interventional

Funder types

Other

Identifiers

NCT00591188

CRT-003

Details and patient eligibility

About

The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC

Enrollment

49 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically or cytologically confirmed renal carcinoma
CT-confirmed metastatic sites
Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
Disease progression after IL-2
Age 18 or older
ECOG performance status 1-3
Life expectancy ≥ 2 months
WBC ≥ 3,000/mm3
Platelet count ≥ 100,000/mm3
Hemoglobin ≥ 7.5 g/dL
Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
Total bilirubin ≤ 1.5 mg/dL
AST ≤ 3.0 times normal
Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
Not pregnant or nursing
No history of autoimmune
No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
No CNS metastases by neurologic exam and/or MRI
No history of seizure disorders
No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
No other malignancy
Written informed consent