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

Cellxpert Biotechnology

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: docetaxel

Drug: PI-88

Study type

Interventional

Funder types

Industry

Identifiers

NCT00097851

PR88202

Details and patient eligibility

About

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.

Full description

PR88202 is an open-label randomized study. In the initial phase of the study, patients will be randomized to receive weekly docetaxel alone, or PI-88 in combination with weekly docetaxel. Both groups will receive docetaxel (30 mg/m2), administered by intravenous infusion on days 1, 8 and 15 of a 28-day cycle. The second group only will receive PI-88 (250 mg/day) in addition to docetaxel; PI-88 will be administered by subcutaneous injection on days 1-4, 8-11 and 15-18 of each cycle. The primary efficacy endpoint is the non-progression rate at 6 months. In the extension phase of the study, patients in the combination arm who have stable disease or an objective response after up to six treatment cycles will remain on PI-88 alone as maintenance therapy. Patients who initially receive docetaxel alone and who have disease progression or unacceptable toxicity before the completion of six cycles will be eligible to receive PI-88 alone as third-line therapy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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