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This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.
This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-007 | Drug |
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Hawkins, M.D. | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abraxis Bioscience, Inc. | Durham | North Carolina | 27703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16258082 | Background | Nyman DW, Campbell KJ, Hersh E, Long K, Richardson K, Trieu V, Desai N, Hawkins MJ, Von Hoff DD. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol. 2005 Nov 1;23(31):7785-93. doi: 10.1200/JCO.2004.00.6148. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |