Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
OBJECTIVES:
Primary
- To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized
nanoparticle formulation in patients with locally advanced (unresectable) or metastatic
pancreatic cancer that failed first-line therapy with a gemcitabine
hydrochloride-containing regimen.
Secondary
- To determine the safety and characterize the toxicity profile of this drug.
- To determine the complete, partial, and overall response rates and duration of response
in patients with measurable disease.
- To determine CA 19-9 response.
- To determine progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes
on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed pancreatic cancer
- Locally advanced (unresectable) or metastatic disease
- Must have failed first-line treatment with a gemcitabine hydrochloride-containing
regimen
- Measurable or nonmeasurable disease by RECIST criteria
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Neutrophils ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No clinical AIDS or known positive HIV serology
- No other concurrent clinically evident malignancy, except inactive nonmelanoma skin
cancer, inactive cervical cancer, or other cancer for which the patient has been
disease-free for 5 years
- No unstable angina
- No New York Heart Association class II-IV congestive heart failure
- No myocardial infarction within the past 3 months
- No stroke within the past 3 months
- No significant traumatic injury within the past 28 days
- No serious medical or psychiatric illness that would render chemotherapy unsafe
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- More than 3 weeks since prior chemotherapy
- More than 2 weeks since prior radiotherapy
- More than 4 weeks since prior major surgery or open biopsy
- More than 4 weeks since prior experimental drug
- At least 3 weeks since other prior therapy
- No concurrent major surgery
- No concurrent radiotherapy
- No other concurrent chemotherapy, immunotherapy, or antitumor hormonal therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival rate at 6 months
Outcome Description:
Overall survival will be measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
Outcome Time Frame:
Overall survival will be measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause.
Safety Issue:
No
Principal Investigator
Caio Max S. Rocha Lima, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Miami Sylvester Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
EPROST-20080055
NCT ID:
NCT00691054
Start Date:
June 2008
Completion Date:
December 2012
Related Keywords:
- Pancreatic Cancer
- recurrent pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
