Intrahepatic Chemotherapy to Patients With Non-resectable... | NCT01511146

Studies
Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor

NCT01511146

Sponsor

Copenhagen University Hospital at Herlev

Status

Unknown status

Last Update Posted

Jan 19, 2012Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Liver Metastasis

Interventions

Oxaliplatin
Mitomycin + Gemcitabine

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

Jan 2012

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

Jul 2011

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Aug 4, 2011

First Submission Date that Met QC Criteria

Jan 12, 2012

First Posted Date

Jan 18, 2012Estimated

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

Jan 18, 2012

Last Update Posted Date

Jan 19, 2012Estimated

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 purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.

Detailed Description

Two regiment are used: N.B. The two regiments will be reported separately

Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitomycin+Gemcitabine	Experimental	Intrahepatic treatment, where all standard treatments have been used	Drug: Oxaliplatin Drug: Mitomycin + Gemcitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	oxaliplatin 85 mg/m2 in 10 minutes	Mitomycin+Gemcitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.		5 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival, adverse events		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

liver metastasis
solid tumor

Exclusion Criteria:

poor performance

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Finn O Larsen, M.D., Ph.D	Unaffliated	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital	Recruiting	Herlev		2730	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D016685	Mitomycin
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D008937	Mitomycins
D045563	Indolequinones

Browse Leaves

Not provided

Browse Branches

Not provided