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

NCT00591188 | Completed Phase 2 DMC

• 1 other identifier: CRT-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Renal Cell

Keywords

kidney cancer, capecitabine, interferon

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (2)

• Evaluate the safety and tolerability of the capecitabine and interferon combination

  one year

• Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens

  one year

Study Arms (1)

1

EXPERIMENTAL

All patients will receive capecitabine and interferon-alpha.

Drug: capecitabine, interferon-alpha

Interventions

capecitabine, interferon-alpha DRUG

Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (1)

N.N. Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Capecitabine; Interferon-alpha

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ilya V. Tsimafeyeu, MD

  Kidney Cancer Research Bureau

  PRINCIPAL INVESTIGATOR

• Lev V. Demidov, MD, DSc.

  N.N. Blokhin Russian Cancer Research Bureau

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 11, 2008
• Study Start: December 1, 2006
• Primary Completion: May 1, 2008
• Last Updated: May 1, 2009

Record last verified: 2009-04

Locations

RU (1)