Spots Global Cancer Trial Database for Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: Trial of PI-88 With Docetaxel in Advanced Non-Small-Cell Lung Cancer (NSCLC)
Official Title: Phase II Trial of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer
Study ID: NCT00097851
Conditions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Sydney Haematology and Oncology Clinics, Hornsby, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Prince Charles Hospital, Chermside, Queensland, Australia
Nambour General Hospital, Nambour, Queensland, Australia
Mater Hospital, South Brisbane, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital, Woodville, South Australia, Australia
The Alfred Hospital, Prahran, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Contact Details
Name: Nick Pavlakis, MD
Affiliation: Royal North Shore Hospital
Role: STUDY_CHAIR
Name: Paul Mitchell, MD
Affiliation: Austin and Repatriation Hospital
Role: STUDY_DIRECTOR
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