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

Theradex

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: paclitaxel-loaded polymeric micelle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111904

WIRB-20050099

CDR0000433513

TARGET-S04-10485

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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