Status:
COMPLETED
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Gemcitabine in Treating Patients With Advanced Metastatic Solid Tumors
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 c...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane) in combination with gemcitabine hydrochlori...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors
- Advanced metastatic disease
- Measurable or evaluable disease
- Must meet 1 of the following criteria:
- Failed prior standard therapy
- Not a candidate for standard therapy
- Has a disease for which there is no defined standard therapy
- No symptomatic brain metastases
- PATIENT CHARACTERISTICS:
- ECOG functional status 0-2
- Life expectancy ≥ 8 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
- AST and ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No prior anaphylactic reaction or severe allergic reaction to paclitaxel, docetaxel, or gemcitabine hydrochloride
- No active infectious process that will require treatment with antibiotics for \> 4 weeks
- No uncontrolled congestive heart failure
- No symptomatic coronary artery disease or heart block
- No myocardial infarction within the past 3 months
- No peripheral neuropathy ≥ grade 2 from any cause
- PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior chemotherapy, radiotherapy, or any other treatment
- No prior radiotherapy to \> 25% of bone marrow
- No prior nitrosoureas
- No more than 6 prior courses of alkylating agents
- No more than 2 prior courses of mitomycin C
- No more than 3 prior courses of cytotoxic therapy for metastatic disease
- No concurrent filgrastim (G-CSF), pegfilgrastim, or sargramostim (GM-CSF) during study course 1
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00307255
Start Date
August 1 2006
End Date
October 1 2008
Last Update
April 4 2012
Active Locations (1)
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1
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599