NCT00016965
BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
PHASE2
COMPLETED
NCT00016965
INTERVENTIONAL
A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
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.
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)
Pancreatic Cancer
- TREATMENT
-
- Type: DRUG
- Name: ixabepilone
- Description:
- Arm Group Labels:
- SWOG Cancer Research Network