NCT01182142

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

2 years

First QC Date

August 11, 2010

Last Update Submit

August 22, 2010

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    12 months

Secondary Outcomes (1)

  • Overall survival Progression-free survival

    24 months

Study Arms (1)

Capecitabine

EXPERIMENTAL

All patients will receive capecitabine.

Drug: Capecitabine

Interventions

CapecitabineDRUG

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

Capecitabine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • metastases in CNS
  • previous targeted therapy
  • other tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natalia Petenko

Moscow, Russia

Location

Related Publications (1)

  • 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.

    PMID: 21358295DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Lev Demidov, MD, D.Sc.

    N.N. Blokhin Russian Cancer Research Center

    PRINCIPAL INVESTIGATOR

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

August 11, 2010

First Posted

August 16, 2010

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

August 1, 2010

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

RU(1)