Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
second-line, combination, chemotherapy, anti-angiogenic
Brief 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.
Detailed 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.
Interventions
DRUGdocetaxel
DRUGPI-88
Sponsors
Medigen Biotechnology Corporation
Cellxpert Biotechnology Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Response rate | — |
| Quality of life | — |
| Overall survival | — |
Countries
Australia
Outcome results
None listed