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

NCT ID: NCT01182142

Last Updated: 2010-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-08-31

Brief Summary

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Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.

Detailed Description

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Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capecitabine

All patients will receive capecitabine.

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

1,250 mg/m2 orally twice a day, days 1-14

Interventions

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Capecitabine

1,250 mg/m2 orally twice a day, days 1-14

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed non-clear cell renal cell carcinoma
* confirmed metastatic sites
* no chemotherapy in history

Exclusion Criteria

* metastases in CNS
* previous targeted therapy
* other tumor
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kidney Cancer Research Bureau

OTHER

Sponsor Role lead

Responsible Party

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N.N. Blokhin Russian Cancer Research Center

Principal Investigators

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Lev Demidov, MD, D.Sc.

Role: PRINCIPAL_INVESTIGATOR

N.N. Blokhin Russian Cancer Research Center

Locations

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Natalia Petenko

Moscow, , Russia

Site Status

Countries

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Russia

References

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Tsimafeyeu I, Demidov L, Kharkevich G, Petenko N, Galchenko V, Sinelnikov I, Naidzionak U. Phase II, multicenter, uncontrolled trial of single-agent capecitabine in patients with non-clear cell metastatic renal cell carcinoma. Am J Clin Oncol. 2012 Jun;35(3):251-4. doi: 10.1097/COC.0b013e31820dbc17.

Reference Type DERIVED
PMID: 21358295 (View on PubMed)

Related Links

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Other Identifiers

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CRT-06.CAP

Identifier Type: -

Identifier Source: org_study_id

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