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.

Condition	Treatment or Intervention	Phase
recurrent pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: DHA-paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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/mm3
• Platelet count at least 100,000/mm3

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
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study

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

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States
Pennsylvania
      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States
Washington
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States
Germany
      Kliniken Essen - Mitte, ESSEN,  D-45136,  Germany
      Krankenhaus Nordwest, Frankfurt,  D-60488,  Germany
Netherlands
      Erasmus Medical Center, Rotterdam,  3008 EA,  Netherlands
United Kingdom, England
      New Cross Hospital, Wolverhampton,  England,  WV10 0QP,  United Kingdom
United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom

Study chairs or principal investigators

Ross C. Donehower, MD,  Study Chair,  Sidney Kimmel Cancer Center   

Study ID Numbers:  CDR0000068926; THERADEX-P01-00-03; PROTARGA-P01-00-03; VMRC-8770
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024375
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08