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Study Summary
No. 2007-0808:.......Advanced Cancers......Carlos A. Jimenez......Pulmonary Medicine
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Study Summary Title
Study Summary
Number:		2007-0808
Study Title:Effectiveness of daily vs. three times a week drainage after placement of intrapleural catheters for the palliative management of pleural effusions associated with malignancies
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Physician New Patient Referral
Name:Carlos A. JimenezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Pulmonary MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-4252
Contact us about clinical trials
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General Information
Disease Group:Advanced CancersSupported By:Care Fusion
Phase of Study:Phase IIReturn
Visit:		12 to 72 hours, two weeks after procedure (+ 1 week), every four weeks (+ 1
week) thereafter as long as IPC is in place (for up to 6 months).
Treatment
Agents:		Indwelling Pleural CatheterHome Care:IPC's are used while the patient is in or out of the hospital. Ample
instructions and teaching materials are provided to patient and caregivers to
continue draining fluid at home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		The goal of this clinical research study is to learn if draining the IPC every
day is better at than draining it 3 times a week.
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Study Objectives / Outcomes
Primary Objective

Our primary objective is to show that draining the intrapleural catheter (IPC) every day (study arm ED) rather than 3 days a week (study arm TDW) results in an earlier removal of the catheter.

Secondary Objectives


To compare on each drainage strategy:
    1.1 Incidence of pleurodesis.
    1.2 Survival after IPC insertion.
    1.3 Incidence of secondary failures after IPC removal.
    1.4 Incidence of partially successful pleurodesis.
    1.5 Incidence of intrapleural catheter related infections.
    1.6 Incidence of intrapleural catheter occlusions.
    1.7 Incidence of other complications (bleeding, pneumothorax, persistent ipsilateral chest pain after IPC insertion).
    1.8 Distance in meters on a six-minute walk test (6MWT) before IPC insertion, after approximately 2 weeks and at the time of removal.
    1.9 Estimated adequate lung re-expansion visualized on radiological studies immediately after IPC insertion, after approximately 2 weeks and at the time of removal
    1.10 ECOG performance status before IPC insertion, after approximately 2 weeks and at the time of removal (Appendix A).
    1.11 Palliation of dyspnea using St. George's respiratory questionnaire. (Appendix B).
    1.12 Quality of life using the EuroQOL (EQ-5D, Appendix D).
    1.13 To compare on pleural fluid samples D-Dimer, TNF-alpha, TGF-beta1, VEGF, PAI-1 and IL-8, at the time of IPC placement, and within 12 to 72 hours, two weeks, and at the time of IPC removal.
    1.14 To compare on peripheral blood samples D-Dimer, TNF-alpha, TGF-beta1, VEGF, PAI-1, hs-CRP and IL-8, at the time of IPC placement, and within 12 to 72 hours, two weeks, and at the time of IPC removal.
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Study Status Information
Study Activation / Registration Date:08/29/2008
IRB Review and Approval Date:08/29/2008
Study Type:Phase Iii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with symptomatic pleural effusion requiring placement of an IPC.

2) Signed informed consent prior to any study related procedures.

3) Subject must be age 18 years or over.
Exclusion Criteria:1) Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.

2) Evidence of empyema or history of empyema of the affected hemithorax

3) Non-correctable bleeding diathesis

4) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

5) Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.

6) Participation in any clinical trial that prevents randomization of the subject to either strategy.

7) Clinical evidence of skin infection at the potential site of IPC placement.
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Links
Registration Number: NCT00761618
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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