Study of Capecitabine in Metastatic Non-clear Cell Renal... | NCT01182142

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

NCT01182142

Sponsor

Kidney Cancer Research Bureau

Status

Completed

Last Update Posted

Aug 24, 2010Estimated

Enrollment

51Estimated

Phase

Phase 2

Conditions

Metastatic Renal Cell Carcinoma

Interventions

Capecitabine

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Aug 2010Actual

First Submitted Date

Aug 11, 2010

First Submission Date that Met QC Criteria

Aug 13, 2010

First Posted Date

Aug 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2010

Last Update Posted Date

Aug 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Capecitabine	Experimental	All patients will receive capecitabine.	Drug: Capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine	Drug	1,250 mg/m2 orally twice a day, days 1-14	Capecitabine

Measure	Description	Time Frame
Overall response rate		12 months

Measure	Description	Time Frame
Overall survival Progression-free survival		24 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lev Demidov, MD, D.Sc.	N.N. Blokhin Russian Cancer Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Natalia Petenko		Moscow			Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21358295	Derived	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.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines