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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medigen Biotechnology Corporation
• Collaborator: Progen Pharmaceuticals
• Treatments: Docetaxel

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