NCT00226798

UnknownPhase 2

Immunochemotherapy for Metastatic Renal Cell Carcinoma

Rambam Health Care Campus Source

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Other study identifiers

Sponsor study identifier

1747CTIL

Secondary identifiers

Raphael Rubinov

Study Type

interventional

Reported enrollment (type unavailable)

45

Locations

1 country

Sites

1

Timeline

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2005

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Reported enrollment (type unavailable): 45 participants
Study completion date: September 2005
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
September 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 26, 2005
Actual (reported)
First Posted
September 27, 2005
Actual (reported)

Last Updated: January 4, 2006
Status Verified: September 2005
Last Update Submitted: December 31, 2005

Conditions

Adenocarcinoma Clear Cell

Outcome Measures

Primary Outcomes (1)

Objective response

Secondary Outcomes (1)

Toxicity

Interventions

Capecitabine (Xeloda)Drug

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Pathological (histology or cytology) diagnosis of renal cell carcinoma
Clinical evidence of metastatic disease

Sponsors & Collaborators

Roche Pharma AG
Industrycollaborator
Rambam Health Care Campus
Otherlead

Study Sites (1)

Rambam medical Center

Haifa, Israel

RECRUITING

Eliahu Gez, MDCONTACT972-4-8542012 e_gez@rambam.health.gov.il

MeSH Terms

Conditions

Adenocarcinoma, Clear Cell

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

Eliahu Gez, MD
Rambam Health Care Campus
STUDY CHAIR

Central Study Contacts

Eliahu Gez, MD

CONTACT

972-4-8542012 e_gez@rambam.health.gov.il

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

September 26, 2005

First Posted

September 27, 2005

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

September 2005

Date type not reported

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A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

Phase 2Completed

NCT00049335

S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

Phase 2Completed

NCT00196820

Mono Efficacy of Capecitabine (MoniCa)

Phase 2Completed

NCT00263705

Adjuvant Capecitabine in Elderly Patients With Breast Cancer: a Phase II Study

Phase 2Completed

NCT01182142

Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

Phase 2Completed

NCT00347438

Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast Cancer

Phase 2Terminated

Performance status 0 - 2 (European Cooperative Oncology Group Score)

Nephrectomy before starting treatment

Normal cardiac function (left ventricular ejection fraction \>45%).

Normal blood counts: WBC \>3,000/ml3, Hb \>10gr%, Platelets \>100,000/ml3

Normal kidney function: Creatinine \<1.3 mg/dl

Age  18 years

Patient's written consent (on informed consent form)

You may not qualify if:

Life expectancy less than 3 months
Brain metastases
Ischemic heart disease - active
Prior immunochemotherapy
Performance status 3 or more (European Cooperative Oncology Group Score)
Schizophrenia
Active liver disease

Contact the study team to confirm eligibility.

Heterocyclic Compounds

Fluorouracil

Uracil

Pyrimidinones

Deoxyribonucleosides

Nucleosides

Nucleic Acids, Nucleotides, and Nucleosides

This date has not been verified as actual or estimated.

Last Updated

January 4, 2006

Record last verified: 2005-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00226798
Data provider: ClinicalTrials.gov
Source updated: 2006-01-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:06 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations