Clinical trial NCT00111904: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-05-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to progression
measure: Time to treatment failure
measure: Best overall response rate
measure: Overall survival
measure: Clinical benefit
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Bonita Springs
country: United States
facility: Florida Cancer Specialists - Bonita Springs
state: Florida
city: Skokie
country: United States
facility: Midwest Cancer Research Group, Incorporated
state: Illinois
city: Lafayette
country: United States
facility: Louisiana Oncology Associates - Lafayette
state: Louisiana
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center - Manhattan
state: New York
city: Austin
country: United States
facility: Southwest Regional Cancer Center - Central
state: Texas
Study officials:
affiliation: Beth Israel Comprehensive Cancer Center - West Side Campus
name: John S. MacDonald, MD
role: STUDY_CHAIR
References:
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.