DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

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

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.

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.

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