Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00307255|
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : April 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: gemcitabine hydrochloride Drug: paclitaxel albumin-stabilized nanoparticle formulation||Phase 1|
- Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine hydrochloride in patients with advanced metastatic solid tumors.
- Evaluate the efficacy of this regimen in these patients.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||October 2008|
- Drug: gemcitabine hydrochloride
1000 mg/m2 on days 1 and 8 of each 21 day cycleOther Name: Gemzar
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
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)Other Name: Abraxane
- Dose Limiting Toxicity (DLT) [ Time Frame: 21 days ]Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
- Maximum Tolerated Dose(MTD) [ Time Frame: 1 year ]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
- Radiographic Response to Treatment [ Time Frame: every 42 days ]Radiographic response will be measured and evaluated using RECIST criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307255
|United States, North Carolina|
|University of North Carolina Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Thomas E. Stinchcombe, MD||UNC Lineberger Comprehensive Cancer Center|