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

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.

Official Title

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

Conditions

Carcinoma, Non-Small-Cell Lung

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Further Details

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.

Study Start

February 2004

Eligibility & Criteria

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria: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

Total Enrolment

100

Contact Details

Brian Creese +61 7 3273 9175 brian.creese@progen.com.auKathy Mackenzie +61 2 3273 9192 kathy.mackenzie@progen.com.auAustralia, Australian Capital TerritoryCanberra Hospital, Canberra, Australian Capital Territory, 2605, Australia; Not yet recruiting Desmond Yip, MD +61 2 6244 2220 dyip@med.usyd.edu.au Jenny May +61 2 6244 3688 Jenny.May@act.gov.au Desmond Yip, MD, Principal InvestigatorAustralia, New South WalesRoyal North Shore Hospital, St. Leonards, New South Wales, 2065, Australia; Recruiting Nick Pavlakis, MD +61 2 9926 5020 pavlakis@med.usyd.edu.au Sally McCowatt +61 2 9926 5049 smccowat@doh.health.nsw.gov.au Nick Pavlakis, MD, Principal InvestigatorSydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia; Recruiting Michael Boyer, MD +61 2 9515 5494 boyer@bigpond.com Annabel Childs +61 2 9515 7028 Annabel.Childs@email.cs.nsw.gov.au Michael Boyer, MD, Principal InvestigatorPrince of Wales Hospital, Randwick, New South Wales, 2031, Australia; Recruiting Craig Lewis, MD +61 2 9382 2606 LewisC@sesahs.nsw.gov.au Clare Bligh +61 2 9382 2466 BlighC@sesahs.nsw.gov.au Craig Lewis, MD, Principal InvestigatorNewcastle Mater Misericordiae Hospital, Waratah, New South Wales, 2298, Australia; Recruiting Fiona Abell, MD +61 2 4921 1148 fiona.abell@mater.health.nsw.gov.au Ian Howitt +61 2 4921 1868 Ian.Howitt@newcastle.edu.au Fiona Abell, MD, Principal InvestigatorSydney Haematology and Oncology Clinics, Hornsby, New South Wales, 2077, Australia; Recruiting Gavin Marx, MD +61 2 9476 5844 gmarx@shoc.com.au Jane Garrad +61 2 9476 5844 jgarrad@shoc.com.au Gavin Marx, MD, Principal InvestigatorConcord Repatriation Hospital, Concord, New South Wales, 2139, Australia; Recruiting Michael Boyer, MD +61 2 9476 5844 boyer@bigpond.com Lili Truong +61 2 9767 5112 lili.truong@email.cs.nsw.gov.au Michael Boyer, MD, Principal InvestigatorAustralia, QueenslandMater Hospital, South Brisbane, Queensland, 4101, Australia; Recruiting Paul Mainwaring, MD +61 7 3840 6166 Paul_Mainwaring@mater.or.au Ken Musgrave +61 7 3840 8697 Ken_Musgrave@mater.org.au Paul Mainwaring, MD, Principal InvestigatorPrince Charles Hospital, Chermside, Queensland, 4032, Australia; Recruiting Rick Abraham, MD +61 2 3350 8520 rcabraham@bigpond.com Jo-Ann Horn +61 7 3212 5863 Joanne_Horn@health.qld.gov.au Rick Abraham, MD, Principal InvestigatorPrincess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia; Not yet recruiting Keith Horwood, MD +61 2 3240 2584 keith@qldoncology.com.au Margaret Dauth +61 2 3240 2584 respmed@health.qld.gov.au Keith Horwood, MD, Principal InvestigatorNambour General Hospital, Nambour, Queensland, 4560, Australia; Not yet recruiting Geoff Hawson, MD +61 418 870 140 geoffrey@hawson.org Chris Cocks +61 7 5470 6202 christine_cocks@health.gld.gov.au Geoffrey Hawson, MD, Principal InvestigatorAustralia, South AustraliaThe Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia; Recruiting Ken Pittman, MD +61 8 8222 6148 Ken’Pittman@nwahs.sa.gov.au Greer Dymott +61 8 8222 8719 Greer.Dymmott@nwahs.sa.gov.au Ken Pittman, MD, Principal InvestigatorAustralia, VictoriaThe Alfred Hospital, Prahran, Victoria, 3187, Australia; Recruiting Jeremy Shapiro, MD +61 3 9509 1866 Jeremy.Shapiro@med.monash.edu.au Sarah Bullen +61 3 9276 2629 S.Bullen@alfred.org.au Jeremy Shapiro, MD, Principal Investigator Border Medical Oncology, Wodonga, Victoria, 3690, Australia; Recruiting Craig Underhill, MD +61 2 6055 3200 CUnderhill@bordermedonc.com.au Chris Hodgkins +61 2 6056 7542 CHodgkins@bordermedonc.com.au Craig Underhill, MD, Principal InvestigatorAustralia, Western AustraliaSir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting Michael Millward, MD +61 8 9346 3823 millward@cyllene.uwa.edu.au Bonnie McLeod +61 8 9346 4438 bonnie.mcleod@health.wa.gov.au Michael Millward, MD, Principal Investigator