Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Docetaxel With PI-88 in Patients With Advanced Non-Small-Cell Lung Cancer|
- Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months [ Designated as safety issue: No ]
- Non-progression rate as measured by RECIST v2.0 at 6 months [ Designated as safety issue: No ]
- Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 [ Designated as safety issue: No ]
- Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 [ Designated as safety issue: No ]
- Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month [ Designated as safety issue: No ]
- Overall survival as measured by RECIST v2.0 at death [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Active Comparator: docetaxel
treated with docetaxel alone
treated with docetaxel and PI-88
- Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.
- Determine the efficacy markers of docetaxel and PI-88 in these patients.
- Determine the safety and potential efficacy of PI-88 alone as maintenance therapy in patients whose disease has been controlled with docetaxel and PI-88 combination therapy.
- Determine the safety and potential efficacy of PI-88 alone as third-line therapy in these patients.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive docetaxel as in arm I. Patients also receive PI-88 subcutaneously once daily on days 1-4, 8-11, and 15-18.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103389
|Australia, New South Wales|
|Sydney Heamatology and Oncology Clinics|
|Hornsby, New South Wales, Australia, 2077|
|Institute of Oncology at Prince of Wales Hospital|
|Randwick, New South Wales, Australia, 2031|
|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|
|Newcastle Mater Misericordiae Hospital|
|Waratah, New South Wales, Australia, 2298|
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia, 4102|
|Prince Charles Hospital|
|Chermside, Queensland, Australia, 4032|
|Nambour General Hospital|
|Nambour, Queensland, Australia, 4560|
|Mater Medical Centre|
|South Brisbane, Queensland, Australia, 4101|
|Australia, South Australia|
|Queen Elizabeth Hospital|
|Woodville, South Australia, Australia, 5011|
|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|