Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Registration Number
- NCT00103389
- Lead Sponsor
- Cellxpert Biotechnology Corp.
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Compare the safety and efficacy of docetaxel with vs without PI-88 in patients with stage IIIB or IV non-small cell lung cancer.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description docetaxel docetaxel treated with docetaxel alone PI-88+docetaxel PI-88 treated with docetaxel and PI-88 PI-88+docetaxel docetaxel treated with docetaxel and PI-88
- Primary Outcome Measures
Name Time Method Non-progression rate as measured by RECIST v2.0 at 6 months Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
- Secondary Outcome Measures
Name Time Method Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6 Overall survival as measured by RECIST v2.0 at death
Trial Locations
- Locations (13)
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Mater Medical Centre
🇦🇺South Brisbane, Queensland, Australia
Sir Charles Gairdner Hospital - Perth
🇦🇺Perth, Western Australia, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Sydney Heamatology and Oncology Clinics
🇦🇺Hornsby, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Institute of Oncology at Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
Nambour General Hospital
🇦🇺Nambour, Queensland, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
🇦🇺Wodonga, Victoria, Australia