Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)

June 21, 2022 updated by: Cellxpert Biotechnology Corp.

Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle. The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle. The primary efficacy endpoint is the non-progression rate at 6 months. In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy. Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Sydney Cancer Centre, Royal Prince Alfred Hospital
      • Hornsby, New South Wales, Australia, 2077
        • Sydney Haematology and Oncology Clinics
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Mater Misericordiae Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Prince Charles Hospital
      • Nambour, Queensland, Australia, 4560
        • Nambour General Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Mater Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Prahran, Victoria, Australia, 3187
        • The Alfred Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment
  • measurable disease by spiral CT chest scan, as defined in RECIST criteria
  • performance status 0-1 (ECOG)
  • life expectancy at least 2 months
  • adequate hemopoietic, renal and hepatic function

Exclusion Criteria:

  • current symptomatic central nervous system (CNS) involvement
  • prior or co-existent malignancies
  • significant non-malignant disease
  • acute or chronic gastrointestinal (GI) bleeding in last two years
  • inflammatory bowel disease
  • abnormal bleeding tendency
  • patients at risk of bleeding due to open wounds or planned surgery
  • clinically significant hemoptysis within the past 4 weeks
  • bilirubin > upper limit of normal (ULN)
  • ALT and AST > 2.5 times ULN, or > 1.5 times ULN if alkaline phosphatase > 2.5 times ULN
  • alkaline phosphatase > 5 times ULN, unless patient has bone metastases
  • myocardial infarction, stroke or congestive heart failure within last 3 months
  • prior treatment with docetaxel
  • concomitant treatment with aspirin (>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors
  • women who are pregnant or breast-feeding
  • women of child-bearing potential not using adequate contraception
  • history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
  • history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease
  • allergy to polysorbate 80 (component of Taxotere®)
  • uncontrolled or serious infection in last 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival

Secondary Outcome Measures

Outcome Measure
Time to progression
Response rate
Overall survival
Quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Nick Pavlakis, MD, Royal North Shore Hospital
  • Study Director: Paul Mitchell, MD, Austin and Repatriation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

November 30, 2004

First Submitted That Met QC Criteria

November 30, 2004

First Posted (Estimate)

December 1, 2004

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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