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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097851
• Other study ID #: PR88202
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: July 2006

Study information

• Verified date: June 2022
• Source: Cellxpert Biotechnology Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• docetaxel

• PI-88

Locations

Country	Name	City	State
Australia	Sydney Cancer Centre, Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Sydney Haematology and Oncology Clinics	Hornsby	New South Wales
Australia	Nambour General Hospital	Nambour	Queensland
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	The Alfred Hospital	Prahran	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Mater Hospital	South Brisbane	Queensland
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Newcastle Mater Misericordiae Hospital	Waratah	New South Wales
Australia	Border Medical Oncology	Wodonga	Victoria
Australia	The Queen Elizabeth Hospital	Woodville	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Cellxpert Biotechnology Corp.	Medigen Biotechnology Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival
Secondary	Time to progression
Secondary	Response rate
Secondary	Quality of life
Secondary	Overall survival