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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Ilya V. Tsimafeyeu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kidney Cancer Research Bureau

Authority:

Russia: Ethics Committee

Study ID:

CRT-003

NCT ID:

NCT00591188

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • kidney cancer, capecitabine, interferon
  • Carcinoma
  • Carcinoma, Renal Cell

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