NCT00226798

Interleukin-2, Interferon Alpha,Capecitabine and Vinblastin for Treatment of Metastatic Renal Cell Carcinoma: A Multicenter Study

Status unknown Phase 2 Last updated 31 December 2005

What this trial tests

Phase 2 trial testing Capecitabine (Xeloda) in Adenocarcinoma Clear Cell in 45 participants. Status unknown.

Timeline

1 December 2003

1 September 2005

Quick facts

Lead sponsor	Rambam Health Care Campus
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 December 2003
Estimated completion	1 September 2005
Sites	1 location across Israel

Drugs / interventions tested

• Capecitabine (Xeloda)

Conditions studied

• Adenocarcinoma Clear Cell — all drugs for Adenocarcinoma Clear Cell →

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

Adults 18 to 80, any sex, with Adenocarcinoma Clear Cell. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Objective response

Sponsor's own description

Immunochemotherapy consisting of IL-2, INF-A, and VBL and 5FU is regarded as the treatment of choice in metastatic renal cell carcinoma. During the period 1996-2000, we evaluated the efficacy and toxicity of this immunochemotherapy, combined with an aggressive surgical approach: nephrectomy before treatment and resection of residual disease. The 3-year survival rate for the entire group and complete responder patients was 30% and 88%, respectively. The side effects were usually moderate and consisted mainly of a flu-like syndrome, headache, nausea, vomiting and depression. Most importantly, there was no drug-related death. Good performance status, absence of bone metastases and prior nephrectomy were associated with higher response rates.

Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively activated to Fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells. Capecitabine at dose of 2,500mg/m2/d divided equally into two daily doses for 14 days in patients who failed to respond to "standard" immunotherapy achieved a 30% objective response. Toxicity consisted of hand-foot syndrome.

Aim of Study:

To evaluate efficacy and toxicity of the combination of IL-2, INF-A, VBL and Capecitabine in MRCC

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metastatic non-clear cell renal cell carcinoma: an evidence based review of current treatment strategies.
   Sankin A, Hakimi AA, Hsieh JJ, Molina AM. · · 2015 · cited 31× · PMID 25905038 · DOI 10.3389/fonc.2015.00067