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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Safety Issue:

No

Principal Investigator

John S. MacDonald, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Comprehensive Cancer Center - West Side Campus

Authority:

United States: Federal Government

Study ID:

CDR0000433513

NCT ID:

NCT00111904

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

St. Vincent's Comprehensive Cancer Center - ManhattanNew York, New York  10011
Midwest Cancer Research Group, IncorporatedSkokie, Illinois  60077
Louisiana Oncology Associates - LafayetteLafayette, Louisiana  70506
Southwest Regional Cancer Center - CentralAustin, Texas  78705
Florida Cancer Specialists - Bonita SpringsBonita Springs, Florida  34135