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

Pancreatic Cancer Clinical Trial

Official title:

Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111904
• Other study ID #: CDR0000433513
• Secondary ID: TARGET-S04-10485
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2005
• Last updated: December 13, 2011
• Start date: May 2005

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• paclitaxel-loaded polymeric micelle

Locations

Country	Name	City	State
United States	Southwest Regional Cancer Center - Central	Austin	Texas
United States	Florida Cancer Specialists - Bonita Springs	Bonita Springs	Florida
United States	Louisiana Oncology Associates - Lafayette	Lafayette	Louisiana
United States	St. Vincent's Comprehensive Cancer Center - Manhattan	New York	New York
United States	Midwest Cancer Research Group, Incorporated	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.3109/0735790090 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression			No
Primary	Time to treatment failure			No
Primary	Best overall response rate			No
Primary	Overall survival			No
Primary	Clinical benefit			No
Primary	Safety			Yes