BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer