NCT00097851

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

First QC Date

November 30, 2004

Last Update Submit

June 21, 2022

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

second-linecombinationchemotherapyanti-angiogenic

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (4)

  • Time to progression

  • Response rate

  • Quality of life

  • Overall survival

Interventions

docetaxelDRUG
PI-88DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sydney Cancer Centre, Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Sydney Haematology and Oncology Clinics

Hornsby, New South Wales, 2077, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Nambour General Hospital

Nambour, Queensland, 4560, Australia

Location

Mater Hospital

South Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3187, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxelphosphomannopentaose sulfate

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Nick Pavlakis, MD

    Royal North Shore Hospital

    STUDY CHAIR

  • Paul Mitchell, MD

    Austin and Repatriation Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2004

First Posted

December 1, 2004

Study Start

February 1, 2004

Study Completion

July 1, 2006

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations

AU(13)