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

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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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

- 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

- 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:


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


United States: Food and Drug Administration

Study ID:




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