Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

PI-88 is a new experimental drug that inhibits tumour growth by reducing the formation of new blood vessels into tumours. Docetaxel is a standard second-line treatment offered to patients with non-small-cell lung cancer who haven't responded to first-line therapies (platinum-based drugs or radiotherapy). Of this group of patients, only 20% remain progression-free 6 months after starting docetaxel treatment. The PR88202 study has been designed to compare two different cancer treatments (docetaxel only, and docetaxel plus PI-88) and to work out which is more effective against the cancer. It is hoped that the combination of PI-88 with docetaxel will allow patients to extend the time it takes for their disease to progress, and also to improve their quality of life.

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

Details

• Lead Sponsor: Medigen Biotechnology Corporation
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• histologically or cytologically confirmed stage IIIb or IV NSCLC that has progressed during or after first-line treatment

• measurable disease by spiral CT chest scan, as defined in RECIST criteria

• performance status 0-1 (ECOG)

• life expectancy at least 2 months

• adequate hemopoietic, renal and hepatic function

Exclusion Criteria:

• current symptomatic central nervous system (CNS) involvement

• prior or co-existent malignancies

• significant non-malignant disease

• acute or chronic gastrointestinal (GI) bleeding in last two years

• inflammatory bowel disease

• abnormal bleeding tendency

• patients at risk of bleeding due to open wounds or planned surgery

• clinically significant hemoptysis within the past 4 weeks

• bilirubin > upper limit of normal (ULN)

• ALT and AST > 2.5 times ULN, or > 1.5 times ULN if alkaline phosphatase > 2.5 times ULN

• alkaline phosphatase > 5 times ULN, unless patient has bone metastases

• myocardial infarction, stroke or congestive heart failure within last 3 months

• prior treatment with docetaxel

• concomitant treatment with aspirin (>100 mg/day), NSAIDs (except selective COX-2 inhibitors, warfarin (>1 mg/day), heparin, LMWH, anti-platelet drugs, CYP3A4 inhibitors

• women who are pregnant or breast-feeding

• women of child-bearing potential not using adequate contraception

• history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin

• history of immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease

• allergy to polysorbate 80 (component of Taxotere®)

• uncontrolled or serious infection in last 4 weeks