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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000561620 | Other Identifier | PDQ number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are assigned to 1 of 3 treatment arms.
Patients in arms I and II undergo blood sample collection periodically for pharmacokinetic studies.
After completion of study treatment, patients are followed at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly Arm | Active Comparator | Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle |
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| Every 3 week Arm | Experimental | Carboplatin day 1, abraxane day 1, every 21 day cycle |
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| Arm C | Experimental | Carboplatin day 1, abraxane day 1, 8 every 21 day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | standard dose of area under the curve (AUC) AUC of 6 in all arms |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Abraxane | To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle | 28 days |
| Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin | To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle | 21 days |
| Sequence-dependent toxicity | To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered | 28 days |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically confirmed solid tumor
Measurable or evaluable disease
Must meet 1 of the following criteria:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Stinchcombe, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
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| Abraxane | Drug | 75mg/m2 - 150 mg/m2 given on days 1, 8, 15 of every 28 day cycle |
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| Abraxane | Drug | 180mg/m2 - 340mg/m2, repeated every 21 days |
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| Abraxane | Drug | 100mg/m2 - 175/mg/m2 given on days 1, 8 of every 21 day cycle |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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