Pancreatic Cancer
Conditions
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, 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 BMS-247550 in treating patients who have advanced pancreatic cancer.
Detailed description
OBJECTIVES: * Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550. * Determine the frequency and severity of toxic effects of this drug in these patients. * Determine the complete and partial response in those patients with measurable disease treated with this drug. * Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 6 months for 2 years and then annually until 3 years after registration. PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study.
Interventions
DRUGixabepilone
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
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 advanced pancreatic adenocarcinoma * Distant metastases OR * Locoregional disease that has failed or is not amenable to locoregional therapy * No de novo locoregional disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * Adult Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte 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 * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No recent myocardial infarction, unstable angina, or life-threatening arrhythmia Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission * No prior severe hypersensitivity reaction to drugs containing Cremophor EL * No active or uncontrolled infection * No severe psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer * No concurrent anticancer immunotherapy Chemotherapy: * No prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer * No other concurrent anticancer chemotherapy Endocrine therapy: * No prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer * No concurrent anticancer hormonal therapy Radiotherapy: * No prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer * Prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy * No concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites Surgery: * At least 2 weeks since prior surgery for pancreatic cancer and recovered Other: * No other concurrent anticancer therapy * No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
Countries
United States
Outcome results
None listed