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Sponsored by: |
Progen Pharmaceuticals Limited |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00103389 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PI-88 may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. It may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with PI-88 may kill more tumor cells. It is not yet known whether giving docetaxel together with PI-88 is more effective than docetaxel alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying docetaxel and PI-88 to see how well they work when given together compared to docetaxel alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: PI-88 Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer |
Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive PI-88 alone as maintenance therapy. Patients in arm I with progressive disease or unacceptable toxicity before the completion of 6 courses may receive PI-88 alone as third-line therapy.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
Eligible for second-line docetaxel
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 3 months:
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent antiplatelet drugs, including any of the following:
No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:
Australia, New South Wales | |
Institute of Oncology at Prince of Wales Hospital | |
Randwick, New South Wales, Australia, 2031 | |
Newcastle Mater Misericordiae Hospital | |
Waratah, New South Wales, Australia, 2298 | |
Royal North Shore Hospital | |
St. Leonards, New South Wales, Australia, 2065 | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2050 | |
Sydney Heamatology and Oncology Clinics | |
Hornsby, New South Wales, Australia, 2077 | |
Australia, Queensland | |
Mater Medical Centre | |
South Brisbane, Queensland, Australia, 4101 | |
Nambour General Hospital | |
Nambour, Queensland, Australia, 4560 | |
Prince Charles Hospital | |
Chermside, Queensland, Australia, 4032 | |
Princess Alexandra Hospital | |
Brisbane, Queensland, Australia, 4102 | |
Australia, South Australia | |
Queen Elizabeth Hospital | |
Woodville, South Australia, Australia, 5011 | |
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Murray Valley Private Hospital and Cancer Treatment Centre | |
Wodonga, Victoria, Australia, 3690 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital - Perth | |
Perth, Western Australia, Australia, 6009 |
Study Chair: | Nick Pavlakis, MD | Royal North Shore Hospital |
Study ID Numbers: | CDR0000409568, PROGEN-PR88202, AUS-RNSH-0309-183M |
Study First Received: | February 7, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00103389 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |