An All-Oral Combination of Capecitabine and Cyclophospham... | NCT00589901

Studies
An All-Oral Combination of Capecitabine and Cyclophosphamide in Patients With Metastatic Breast Cancer (MBC)

NCT00589901

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 18, 2008Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

capecitabine and cyclophosphamide

Countries

China

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Jan 9, 2008

First Posted Date

Jan 10, 2008Estimated

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

Apr 17, 2008

Last Update Posted Date

Apr 18, 2008Estimated

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

The primary objective of this study is to evaluate the time to progression. Secondary objectives are safety, OS and pharmacogenetic analysis. Sixty patients will be enrolled into this study.

Detailed Description

Xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	phase II trial of capecitabine and cyclophosphamide in the management of metastatic breast cancer	Drug: capecitabine and cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
capecitabine and cyclophosphamide	Drug	capecitabine 1000 mg/m2 oral Bid d1-14 cyclophosphamide 65 mg/m2 oral Qd d1-14	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TTP (first treatment of this regimen to disease progression)		every two cycles

Secondary Outcomes

Measure	Description	Time Frame
side effects		all cycles
pharmacogenetic analysis		collect blood samples before this therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed breast cancer
Anthracycline and taxane pretreated metastatic breast cancer
Have not been previously treated with capecitabine
ECOG performance status of ≤ 1
Are female and ≥ 18 and ≤ 70 years of age
Have at least one target lesion according to the RECIST criteria

Exclusion Criteria:

Pregnant or lactating women
ECOG ≥ 2
Have been treated with capecitabine
Evidence of CNS metastasis
History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
Abnormal laboratory values: hemoglobin < 8.0 g/dl, neutrophils < 1.5×10^9/L, platelets < 100×10^9/L, serum creatinine > upper limit of normal (ULN), serum bilirubin > ULN, ALT and AST > 5×ULN, AKP > 5×ULN
Serious uncontrolled intercurrent infection
Life expectancy of less than 3 months

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhonghua Wang, MD	Contact	8613918322628		zhonghuawang95@hotmail.com

Overall Officials

Name	Affiliation	Role
Zhonghua Wang, MD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital	Recruiting	Shanghai	Shanghai Municipality	+86200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14962720	Background	Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Cure H, Vuillemin E, Morere JF, Montestruc F, Mouri Z, Namer M. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004 Mar;40(4):536-42. doi: 10.1016/j.ejca.2003.11.007.
10449619

Type	Date	Date Unknown
Release	Feb 11, 2010
Reset	Feb 26, 2010
Release	May 25, 2010
Reset	Jun 18, 2010
Release	Jul 9, 2010
Reset	Aug 9, 2010
Release	Mar 16, 2011
Reset	Apr 15, 2011
Release	Jul 1, 2011
Reset	Jul 29, 2011

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 11, 2010			Feb 26, 2010
May 25, 2010

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

ID	Term
D000069287	Capecitabine
D003520	Cyclophosphamide