A Phase II Study of Gemcitabine and Capecitabine for Trea... | NCT01472770

Studies
A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

NCT01472770

Sponsor

Vejle Hospital

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

49Actual

Phase

Phase 2

Conditions

Metastatic Colorectal Cancer

Interventions

Gemcitabine + Capecitabine

Countries

Denmark

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

Dec 2014

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

Oct 2011

Primary Completion Date

May 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Nov 1, 2011

First Submission Date that Met QC Criteria

Nov 11, 2011

First Posted Date

Nov 16, 2011Estimated

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

Dec 3, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.

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

49Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine + Capecitabine	Drug	Gemcitabine: 1000 mg/m2 intravenously over 30 min. on day 1 in 2-weeks cycles. Capecitabine: Peroral tablet 2000 mg/m2 daily on days 1-7 in 2-weeks cycles.

Measure	Description	Time Frame
Rate of patients progression free at 3 months		3 months after start of treatment

Measure	Description	Time Frame
Progression free survival		Every 12 weeks
Overall survival		Every 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically verified colorectal adenocarcinomas
Age > 18 years
Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
Measurable disease according to RECIST 1.1
ECOG performance status 0, 1 or 2
Adequate renal, hepatic and haematological function
Consent to blood samples and available paraffin embedded tumour material for translational research studies
Fertile males and females (<2 years after last period for women) must use effective birth control.
Signed Informed consent

Exclusion Criteria:

Clinically significant concurrent disease.
Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
Other experimental therapy within 30 days of treatment initiation.
Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
Clinical or radiological evidence of CNS metastasis.
Planned radiation therapy against target-lesions.
Known allergy to 5FU/capecitabine or gemcitabine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department of Oncology, Vejle Hospital		Vejle		7100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D000069287	Capecitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided