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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PI-88
docetaxel
Sponsored by
Cellxpert Biotechnology Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sydney Heamatology and Oncology Clinics
  • Institute of Oncology at Prince of Wales Hospital
  • Royal North Shore Hospital
  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Newcastle Mater Misericordiae Hospital
  • Princess Alexandra Hospital
  • Prince Charles Hospital
  • Nambour General Hospital
  • Mater Medical Centre
  • Queen Elizabeth Hospital
  • Alfred Hospital
  • Murray Valley Private Hospital and Cancer Treatment Centre
  • Sir Charles Gairdner Hospital - Perth

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

docetaxel

PI-88+docetaxel

Arm Description

treated with docetaxel alone

treated with docetaxel and PI-88

Outcomes

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

Full Information

First Posted
February 7, 2005
Last Updated
June 21, 2022
Sponsor
Cellxpert Biotechnology Corp.
Collaborators
Medigen Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00103389
Brief Title
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellxpert Biotechnology Corp.
Collaborators
Medigen Biotechnology Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
docetaxel
Arm Type
Active Comparator
Arm Description
treated with docetaxel alone
Arm Title
PI-88+docetaxel
Arm Type
Experimental
Arm Description
treated with docetaxel and PI-88
Intervention Type
Drug
Intervention Name(s)
PI-88
Intervention Description
PI-88+docetaxel
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
docetaxel only
Primary Outcome Measure Information:
Title
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Title
Non-progression rate as measured by RECIST v2.0 at 6 months
Secondary Outcome Measure Information:
Title
Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Title
Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Title
Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Title
Overall survival as measured by RECIST v2.0 at death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Pavlakis, MD
Organizational Affiliation
Royal North Shore Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sydney Heamatology and Oncology Clinics
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Institute of Oncology at Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Nambour General Hospital
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Mater Medical Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Murray Valley Private Hospital and Cancer Treatment Centre
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Sir Charles Gairdner Hospital - Perth
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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