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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000550136 | Other Identifier | PDQ number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with gemcitabine in treating patients with advanced metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane).
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) IV over 30 minutes on day 1 followed by gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients may be treated at the MTD.
After completion of study treatment, patients are followed at 30 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | 1000 mg/m2 on days 1 and 8 of each 21 day cycle |
| |
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | 260 mg/m2 to 340 mg/m2 (dose will depend on when subject enters the study). Paclitaxel will be given on day 1 of each 21 day cycle (every 3 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days) | 21 days |
| Maximum Tolerated Dose(MTD) | If greater than or equal to 2 of 6 patients (33%) experience a DLT, then that dose level will be considered to have excessive toxicity and will = MTD | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response to Treatment | Radiographic response will be measured and evaluated using RECIST criteria. | every 42 days |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors
Measurable or evaluable disease
Must meet 1 of the following criteria:
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Stinchcombe, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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