Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Principal Investigator
Nick Pavlakis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Royal North Shore Hospital
Authority:
United States: Food and Drug Administration
Study ID:
PR88202
NCT ID:
NCT00097851
Start Date:
February 2004
Completion Date:
July 2006
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- second-line
- combination
- chemotherapy
- anti-angiogenic
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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