Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose Limiting Toxicity (DLT)
Outcome Description:
Toxicity will be graded using the CTCAE version 3.0 and will be assessed on cycle one (21 days)
Outcome Time Frame:
21 days
Safety Issue:
Yes
Principal Investigator
Thomas E. Stinchcombe, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
LCCC 0520
NCT ID:
NCT00307255
Start Date:
August 2006
Completion Date:
October 2008
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor
- protocol specific
- Paclitaxel
- Abraxane
- Gemcitabine
- Gemzar
- Phase I
- Lineberger
- Neoplasms
Name | Location |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |
