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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: docetaxel
* Drug: PI-88


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: PI-88|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Response rate |  |  | 
| Quality of life |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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second-line, combination, chemotherapy, anti-angiogenic