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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00097851
Recruitment Status : Completed
First Posted : December 1, 2004
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
Medigen Biotechnology Corporation

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: docetaxel Drug: PI-88 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Study Start Date : February 2004
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Time to progression
  2. Response rate
  3. Quality of life
  4. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00097851

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Australia, New South Wales
Sydney Cancer Centre, Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Sydney Haematology and Oncology Clinics
Hornsby, New South Wales, Australia, 2077
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Mater Hospital
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
The Alfred Hospital
Prahran, Victoria, Australia, 3187
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Medigen Biotechnology Corporation
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Study Chair: Nick Pavlakis, MD Royal North Shore Hospital
Study Director: Paul Mitchell, MD Austin and Repatriation Hospital
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Responsible Party: Medigen Biotechnology Corporation Identifier: NCT00097851    
Other Study ID Numbers: PR88202
First Posted: December 1, 2004    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by Medigen Biotechnology Corporation:
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action