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Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel-loaded polymeric micelle
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Cancer Specialists - Bonita Springs
  • Midwest Cancer Research Group, Incorporated
  • Louisiana Oncology Associates - Lafayette
  • St. Vincent's Comprehensive Cancer Center - Manhattan
  • Southwest Regional Cancer Center - Central

Outcomes

Primary Outcome Measures

Time to progression
Time to treatment failure
Best overall response rate
Overall survival
Clinical benefit
Safety

Secondary Outcome Measures

Full Information

First Posted
May 26, 2005
Last Updated
December 13, 2011
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00111904
Brief Title
Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Official Title
Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel-loaded polymeric micelle
Primary Outcome Measure Information:
Title
Time to progression
Title
Time to treatment failure
Title
Best overall response rate
Title
Overall survival
Title
Clinical benefit
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S. MacDonald, MD
Organizational Affiliation
Beth Israel Comprehensive Cancer Center - West Side Campus
Official's Role
Study Chair
Facility Information:
Facility Name
Florida Cancer Specialists - Bonita Springs
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Midwest Cancer Research Group, Incorporated
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Louisiana Oncology Associates - Lafayette
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center - Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Southwest Regional Cancer Center - Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19968498
Citation
Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591.
Results Reference
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Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

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