Clinical trial NCT00024375: DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Essen
country: Germany
facility: Kliniken Essen - Mitte
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Ross C. Donehower, MD
role: STUDY_CHAIR
References: