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

NCT ID: NCT00103389

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2007-05-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

docetaxel

treated with docetaxel alone

Group Type: ACTIVE_COMPARATOR

docetaxel

Intervention Type: DRUG

docetaxel only

PI-88+docetaxel

treated with docetaxel and PI-88

Group Type: EXPERIMENTAL

PI-88

Intervention Type: DRUG

PI-88+docetaxel

docetaxel

Intervention Type: DRUG

docetaxel only

Interventions

PI-88

PI-88+docetaxel

Intervention Type: DRUG

docetaxel

docetaxel only

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medigen Biotechnology Corporation

INDUSTRY

Sponsor Role: collaborator

Cellxpert Biotechnology Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Pavlakis, MD

Role: STUDY_CHAIR

Royal North Shore Hospital

Locations

Sydney Heamatology and Oncology Clinics

Hornsby, New South Wales, Australia

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Prince Charles Hospital

Chermside, Queensland, Australia

Nambour General Hospital

Nambour, Queensland, Australia

Mater Medical Centre

South Brisbane, Queensland, Australia

Queen Elizabeth Hospital

Woodville, South Australia, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, Australia

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

CDR0000409568

Identifier Type: REGISTRY

Identifier Source: secondary_id

AUS-RNSH-0309-183M

Identifier Type: -

Identifier Source: secondary_id

PROGEN-PR88202

Identifier Type: -

Identifier Source: org_study_id