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Combined Treatment With Capecitabine and Immunotherapy Versus Immunotherapy Alone in Advanced Renal Cell Carcinoma

2014-08-27 03:45:21 | BioPortfolio

Summary

Multi-center, prospective randomised phase III study evaluating capecitabine in combination with standard-immunotherapy versus standard-immunotherapy alone as first-line therapy in patients with metastatic renal cell carcinoma.

Description

Treatment plan Group A

Patients randomised to group A will receive treatment according to the following treatment schedule:

Group A: Combined Chemo-Immunotherapy Chemotherapy: Mo-Fr Immunotherapy

- Week 1:Capecitabine / Interferon;

- Week 2:Capecitabine / Interferon;

- Week 3:REST PERIOD / Interleukin;

- Week 4:Capecitabine / Interleukin;

- Week 5:Capecitabine / REST PERIOD;

- Week 6:REST PERIOD / Interferon;

- Week 7:Capecitabine / Interferon;

- Week 8:Capecitabine / Interleukin;

- Week 9:REST PERIOD / Interleukin;

- Week 10:Capecitabine / REST PERIOD;

- Week 11:Capecitabine / Interferon;

- Week 12:REST PERIOD / Interferon;

- Week 13:Capecitabine / Interleukin;

- Week 14:Capecitabine / Interleukin;

DOSAGES AND ROUTES OF ADMINISTRATION:

Capecitabine orally from day 1 to 14 at a dose of 1000 mg/m2 twice daily every 21 days.

Interferon-alpha subcutaneously on days 1 + 3 + 5 weeks 1 + 2 +6 + 7,11+12 at a dose of 6 MIU/d.

Interleukin-2 subcutaneously on days 1 to 4 in weeks 3 + 4 +8 + 9,13+14 at a dose of 4.5 MIU/day.

Group B

Patients randomized to group B will receive treatment according to the same treatment schedule and at the same dosages without capecitabine.

Efficacy evaluations will be performed every 14 weeks of treatment in both groups

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Cell Cancer

Intervention

Capecitabine, Interferon, Interleukin

Location

Univ. Klinik f. Innere Medizin, Abt. Onkologie
Vienna
Austria
1090

Status

Terminated

Source

Central European Cooperative Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:21-0400

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A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Cell surface receptors for INTERLEUKIN-13. Included under this heading are the INTERLEUKIN-13 RECEPTOR ALPHA2 which is a monomeric receptor and the INTERLEUKIN-4 RECEPTOR TYPE II which has specificity for both INTERLEUKIN-4 and INTERLEUKIN-13.

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Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

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