Study of Carboplatin and Vinorelbine in Malignant Pleural... | NCT00272558

Studies
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma

NCT00272558

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Malignant Pleural Mesothelioma

Interventions

Carboplatin and Vinorelbine

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

Sep 2009

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 2004

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jan 3, 2006

First Submission Date that Met QC Criteria

Jan 3, 2006

First Posted Date

Jan 6, 2006Estimated

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

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Description Module

Brief Summary

The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

Detailed Description

Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.

Endpoint is response rate, secondary endpoints survival and toxicity.

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

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin and Vinorelbine	Drug

Measure	Description	Time Frame
Response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically verified malignant pleural Mesothelioma
Age above 18 years
Performance status 0-2

Exclusion Criteria:

No previous chemotherapy
Normal renal, liver and bone marrow function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
Jens B Sorensen, MD	Dept. Oncology, Rigshospitalet	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Oncol., Rigshospitalet		Copenhagen	Copenhagen	2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000086002	Mesothelioma, Malignant

Ancestor Terms

ID	Term
D008654	Mesothelioma
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016190	Carboplatin
D000077235	Vinorelbine

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided