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Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Abraxane in Combination With Gemcitabine in Patients With Solid Tumors



- 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.

Inclusion Criteria


- 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


- 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

- 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

- 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


- 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:


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:


Principal Investigator

Thomas E. Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

LCCC 0520



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



University of North Carolina Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599