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Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Progen Pharmaceuticals
Information provided by (Responsible Party):
Medigen Biotechnology Corporation Identifier:
First received: February 7, 2005
Last updated: August 30, 2016
Last verified: August 2016

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer Drug: PI-88 Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Medigen Biotechnology Corporation:

Primary Outcome Measures:
  • Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
  • Non-progression rate as measured by RECIST v2.0 at 6 months

Secondary Outcome Measures:
  • Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
  • Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
  • Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
  • Overall survival as measured by RECIST v2.0 at death

Enrollment: 98
Study Start Date: February 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: docetaxel
treated with docetaxel alone
Drug: docetaxel
docetaxel only
Experimental: PI-88+docetaxel
treated with docetaxel and PI-88
Drug: PI-88
Drug: docetaxel
docetaxel only

Detailed Description:



  • Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.


  • Determine the efficacy markers of docetaxel and PI-88 in these patients.
  • Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.
  • Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.
  • Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88 subcutaneously once daily on days 1-4, 8-11, and 15-18.

In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of non-small cell lung cancer

    • Stage IIIB or IV disease
  • Eligible for second-line docetaxel

    • Disease progression during or after completion of prior first-line therapy comprising radiotherapy and/or platinum-based chemotherapy



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 2 months


  • Neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • WBC > 3,000/mm^3
  • No history of thrombotic thrombocytopenic purpura or other platelet disease


  • Bilirubin normal
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
  • Alkaline phosphatase ≤ 5 times ULN (unless bone metastases are present)
  • PT < 1.5 times ULN
  • Activated PTT normal


  • Creatinine clearance or glomerular filtration rate > 50mL/min


  • None of the following within the past 3 months:

    • Myocardial infarction
    • Stroke
    • Congestive heart failure


  • No history of immune-mediated thrombocytopenia
  • No evidence of anti-heparin antibodies
  • No history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
  • No history of allergy to polysorbate 80
  • No uncontrolled or serious infection within the past 4 weeks


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No prior docetaxel

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 3 months since prior radiotherapy to > 30% of marrow-bearing bone
  • Concurrent local palliative radiotherapy allowed


  • More than 4 weeks since prior major surgery


  • More than 4 weeks since prior antineoplastic therapy
  • More than 2 weeks since prior and no concurrent heparin or low-molecular weight heparin
  • More than 4 weeks since prior investigational therapy
  • No concurrent aspirin or aspirin-containing medications except low-dose aspirin (≤ 100 mg/day)
  • No concurrent nonsteroidal anti-inflammatory drugs except cyclooxygenase-2 inhibitors
  • No concurrent warfarin or warfarin-containing medications except low-dose warfarin (≤ 1 mg/day)
  • No concurrent antiplatelet drugs, including any of the following:

    • Abciximab
    • Clopidogrel
    • Dipyridamole
    • Ticlopidine
    • Tirofiban
  • No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:

    • Cyclosporine
    • Terfenadine
    • Ketoconazole
    • Erythromycin
    • Troleandomycin
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00103389

Australia, New South Wales
Sydney Heamatology and Oncology Clinics
Hornsby, New South Wales, Australia, 2077
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Mater Medical Centre
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Medigen Biotechnology Corporation
Progen Pharmaceuticals
Study Chair: Nick Pavlakis, MD Royal North Shore Hospital
  More Information

Responsible Party: Medigen Biotechnology Corporation Identifier: NCT00103389     History of Changes
Other Study ID Numbers: PROGEN-PR88202
CDR0000409568 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: February 7, 2005
Last Updated: August 30, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medigen Biotechnology Corporation:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017