Skip to content

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

A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00103389
Enrollment
98
Registered
2005-02-08
Start date
2004-02-29
Completion date
2007-05-31
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

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.

Interventions

DRUGPI-88

PI-88+docetaxel

DRUGdocetaxel

docetaxel only

Sponsors

Medigen Biotechnology Corporation
CollaboratorINDUSTRY
Cellxpert Biotechnology Corp.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026