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CompletedNCT00103389Updated Jun 27, 2022

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

A Phase 2 interventional study of PI-88 and docetaxel in Lung Cancer, sponsored by Cellxpert Biotechnology Corp.. Completed at 13 sites in Australia. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-06-27.

Sponsored by Cellxpert Biotechnology Corp. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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 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.

Read the 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 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 98 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Cellxpert Biotechnology Corp. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Active comparator
    docetaxel

    treated with docetaxel alone

    Drug: docetaxel

  • Experimental
    PI-88+docetaxel

    treated with docetaxel and PI-88

    Drug: PI-88 · Drug: docetaxel

Interventions

  • DrugPI-88

    PI-88+docetaxel

  • Drugdocetaxel

    docetaxel only

06

What researchers measure

Primary outcomes

  1. Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months

  2. Non-progression rate as measured by RECIST v2.0 at 6 months

Secondary outcomes

  1. Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6

  2. Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6

  3. Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month

  4. Overall survival as measured by RECIST v2.0 at death

07

Study locations

13 sites
  • Sydney Heamatology and Oncology Clinics
    Hornsby, New South Wales 2077, Australia
  • Institute of Oncology at Prince of Wales Hospital
    Randwick, New South Wales 2031, Australia
  • Royal North Shore Hospital
    St. Leonards, New South Wales 2065, Australia
  • Sydney Cancer Centre at Royal Prince Alfred Hospital
    Sydney, New South Wales 2050, Australia
  • Newcastle Mater Misericordiae Hospital
    Waratah, New South Wales 2298, Australia
  • Princess Alexandra Hospital
    Brisbane, Queensland 4102, Australia
  • Prince Charles Hospital
    Chermside, Queensland 4032, Australia
  • Nambour General Hospital
    Nambour, Queensland 4560, Australia
  • Mater Medical Centre
    South Brisbane, Queensland 4101, Australia
  • Queen Elizabeth Hospital
    Woodville, South Australia 5011, Australia
  • Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Murray Valley Private Hospital and Cancer Treatment Centre
    Wodonga, Victoria 3690, Australia
  • Sir Charles Gairdner Hospital - Perth
    Perth, Western Australia 6009, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00103389
Lead sponsor
Cellxpert Biotechnology Corp.
Collaborators
Medigen Biotechnology Corporation
Responsible party
Sponsor
First posted
Feb 8, 2005
Start date
Feb 2004
Primary completion
May 2007
Completion
May 2007
Last update
Jun 27, 2022

Study contacts

Nick Pavlakis, MD
study chair · Royal North Shore Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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