Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer
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.
Interventions
DRUGDHA-paclitaxel
Sponsors
Theradex
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
Germany, Netherlands, United Kingdom, United States
Outcome results
None listed