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

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: NCT00103389
Recruitment Status : Completed
First Posted : February 8, 2005
Last Update Posted : August 31, 2016
Progen Pharmaceuticals
Information provided by (Responsible Party):
Medigen Biotechnology Corporation

February 7, 2005
February 8, 2005
August 31, 2016
February 2004
May 2007   (Final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT00103389 on Archive Site
  • 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
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Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

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.



  • 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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
  • Drug: PI-88
  • Drug: docetaxel
    docetaxel only
  • Active Comparator: docetaxel
    treated with docetaxel alone
    Intervention: Drug: docetaxel
  • Experimental: PI-88+docetaxel
    treated with docetaxel and PI-88
    • Drug: PI-88
    • Drug: docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
May 2007
May 2007   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000409568 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Plan to Share IPD: No
Medigen Biotechnology Corporation
Medigen Biotechnology Corporation
Progen Pharmaceuticals
Study Chair: Nick Pavlakis, MD Royal North Shore Hospital
Medigen Biotechnology Corporation
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP