A Phase 1 interventional study of paclitaxel and paclitaxel albumin-stabilized nanoparticle formulation in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-15.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study.
Courses 1 and 2: Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
Browse Neoplasms studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant solid tumor
Likely to be responsive to taxane-based therapy
No symptomatic or untreated brain metastasis or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)