A Phase 2 interventional study of PI-88 and docetaxel in Lung Cancer, sponsored by Cellxpert Biotechnology Corp.. Completed at 13 sites in Australia. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Cellxpert Biotechnology Corp. · Phase 2, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 98 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Cellxpert Biotechnology Corp. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
treated with docetaxel alone
Drug: docetaxel
treated with docetaxel and PI-88
Drug: PI-88 · Drug: docetaxel
PI-88+docetaxel
docetaxel only
Proportion of patients who are progression-free as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v2.0 at 6 months
Non-progression rate as measured by RECIST v2.0 at 6 months
Time to progression as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Response rate as measured by RECIST v2.0 at baseline, and then week 4 of courses 2, 3, 4, and 6
Quality of life as measured by Lung Cancer Symptom Scale (LCSS) every month
Overall survival as measured by RECIST v2.0 at death
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Cellxpert Biotechnology Corp.