- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111904
Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
- Determine the best overall response rate and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit and safety of this drug in these patients.
OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Bonita Springs, Florida, United States, 34135
- Florida Cancer Specialists - Bonita Springs
-
-
Illinois
-
Skokie, Illinois, United States, 60077
- Midwest Cancer Research Group, Incorporated
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-
Louisiana
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Lafayette, Louisiana, United States, 70506
- Louisiana Oncology Associates - Lafayette
-
-
New York
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New York, New York, United States, 10011
- St. Vincent's Comprehensive Cancer Center - Manhattan
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Texas
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Austin, Texas, United States, 78705
- Southwest Regional Cancer Center - Central
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed epithelial carcinoma of the pancreas
- Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
- No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
- No unstable or serious medical condition
- No psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
No prior chemotherapy for pancreatic cancer
- Prior fluorouracil as a radiosensitizer allowed
Endocrine therapy
- Not specified
Radiotherapy
More than 6 weeks since prior radiotherapy for pancreatic cancer
- Disease must have progressed after completion of radiotherapy
Surgery
- More than 14 days since prior major surgery and recovered
Other
- More than 30 days since prior investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to progression
|
Time to treatment failure
|
Overall survival
|
Safety
|
Clinical benefit
|
Best overall response rate
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- CDR0000433513
- TARGET-S04-10485
- WIRB-20050099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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