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Status:

COMPLETED

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

Lead Sponsor:

Cellxpert Biotechnology Corp.

Collaborating Sponsors:

Medigen Biotechnology Corporation

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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 gr...

Detailed Description

OBJECTIVES: Primary * Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer. Secondary * Determine the efficacy markers of...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • At least 2 months
  • Hematopoietic
  • 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
  • Hepatic
  • 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
  • Renal
  • Creatinine clearance or glomerular filtration rate \> 50mL/min
  • Cardiovascular
  • None of the following within the past 3 months:
  • Myocardial infarction
  • Stroke
  • Congestive heart failure
  • Immunologic
  • 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
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • See Disease Characteristics
  • No prior docetaxel
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • More than 3 months since prior radiotherapy to \> 30% of marrow-bearing bone
  • Concurrent local palliative radiotherapy allowed
  • Surgery
  • More than 4 weeks since prior major surgery
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2007

    Estimated Enrollment :

    98 Patients enrolled

    Trial Details

    Trial ID

    NCT00103389

    Start Date

    February 1 2004

    End Date

    May 1 2007

    Last Update

    June 27 2022

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    Sydney Heamatology and Oncology Clinics

    Hornsby, New South Wales, Australia, 2077

    2

    Institute of Oncology at Prince of Wales Hospital

    Randwick, New South Wales, Australia, 2031

    3

    Royal North Shore Hospital

    St Leonards, New South Wales, Australia, 2065

    4

    Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, Australia, 2050