Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy

NCT00607880 | Completed Phase 2 Results DMC

• 2 other identifiers: P30CA01508352-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use. PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific; Vascular Access Device Complications

Keywords

vascular access device complications; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Port Failure Within 12 Months of Port Insertion

  We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.

  Up to 12 months from port insertion

Secondary Outcomes (3)

• Death From All Causes

  Up to 12 months after port insertion

• Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion

  Up to 12 months after port insertion

• Termination of Use of the Indwelling Port at 12 Months After Port Insertion

  Up to 12 months after port insertion

Study Arms (2)

Standard Port

ACTIVE COMPARATOR

Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.

Procedure: vascular access device placement

Vortex Implantable Access Port

EXPERIMENTAL

Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.

Procedure: vascular access device placement

Interventions

vascular access device placement PROCEDURE

Standard Port; Vortex Implantable Access Port

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months * Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic * Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following: * Current skin infection * Cutaneous lymphoma * Auto-immune disorders * Active vasculitis * Connective tissue diseases * No known active infection requiring antibiotic therapy at the time of port implantation * Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible * No concurrent illness requiring chronic anticoagulation * Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Results Point of Contact

• Title: Albert G. Hakaim, M.D.
• Organization: Mayo Clinic

Hakaim.Albert@mayo.edu

Study Officials

• Albert G. Hakaim, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 6, 2008
• Study Start: June 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 9, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-04

Locations

US (1)