DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00024375
• Other study ID #: CDR0000068926
• Secondary ID: THERADEX-P01-00-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: February 17, 2009
• Start date: June 2001

Study information

• Verified date: March 2003
• 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 use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

Description:

OBJECTIVES:

• Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel.

• Determine the overall survival of patients treated with this drug.

• Determine the toxicity profile of this drug in these patients.

• Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed carcinoma of the pancreas

• Metastatic disease

• Measurable disease

• Lesions within a previously irradiated field are not considered measurable

• No islet cell tumors, lymphoma, or sarcoma of the pancreas

• 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 at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled ventricular arrhythmia

• No myocardial infarction within the past 3 months

• No superior vena cava syndrome

Neurologic:

• No peripheral neuropathy greater than grade 1

• No uncontrolled major seizure disorder

• No spinal cord compression

Other:

• No concurrent serious infection requiring parenteral therapy

• No unstable or serious concurrent medical condition

• No other prior malignancy except:

• Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR

• Other cancer curatively treated with surgery alone that has not recurred for more than 5 years

• No psychiatric disorder that would preclude study compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy for metastatic disease

• Prior adjuvant chemoradiotherapy allowed

• At least 28 days since prior chemotherapy and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except megestrol

Radiotherapy:

• See Disease Characteristics

• Prior adjuvant chemoradiotherapy allowed

• At least 28 days since prior large-field radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• At least 14 days since prior major surgery and recovered

Other:

• No other concurrent anticancer therapy

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• DHA-paclitaxel

Locations

Country	Name	City	State
Germany	Kliniken Essen - Mitte	Essen
Germany	Krankenhaus Nordwest	Frankfurt
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	New Cross Hospital	Wolverhampton	England
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  United Kingdom,