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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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