SWOG clinical trial number
S0107

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

Closed
Phase
Accrual
100%
Published
Abbreviated Title
PANCREAS
Activated
07/01/2001
Closed
06/01/2003
Participants

Research committees

Gastrointestinal Cancer

Treatment

BMS-247550

Eligibility Criteria Expand/Collapse

Cytologically or pathologically verified diagnosis of pancreatic adenocarcinoma. One of the following: distant metastatic disease or recurrent disease not amenable to curative resection (in the opinion of the treating investigator). Patients may have had prior surgery for their pancreas cancer and at least 2 weeks beyond surgery, and recovered from all effects. No prior chemotherapy, hormonal therapy, immunotherapy, radiation or chemoradiotherapy as neoadjuvant or adjuvant treatment or as treatment for advanced pancreas cancer. Prior palliative radiation therapy allowed if at least one lesion outside radiation therapy field or at least one lesion has progressed since radiation therapy. Zubrod performance status 0 - 1. No other prior malignancy allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in remission or any other cancer from which the patient has been disease-free for 5 years. No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of their cancer while on protocol. Radiation for palliation to metastatic sites allowed as long as the target lesions are not irradiated. No history of severe hypersensitivity reaction to drugs containing a cremaphor delivery vehicle. No evidence of active or uncontrolled infection, recent myocardial infarction, unstable angina, or life-threatening arrhythmia. No severe psychiatric disorders. Non-pregnant non-nursing. No known brain metastases. If brain imaging studies are performed, they must be negative for disease.

Publication Information Expand/Collapse

2014

Historical controls for metastatic pancreatic cancer: benchmarks for planning and analyzing single arm phase II trials

PA Philip;K Chansky;L Rubenstein;M Leblanc;L Seymour;SP Ivy;SR Alberts;PJ Catalano;J Crowley Clinical Cancer Research 20(16):4176-4185;

PMid: PMID24914040 | PMC number: PMC4296727

2006

A phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: a Southwest Oncology Group study

RP Whitehead;S McCoy;SE Rivkin;HM Gross;ME Conrad;GC Doolittle;RA Wolff;JW Goodwin;SR Dakhil;JL Abbruzzese Investigational New Drugs 24:515-520

2004

A phase II trial of epothilone B analogue BMS-247550 (NSC# 710428) in patients with advanced pancreas cancer: a Southwest Oncology Group study

RP Whitehead;SA McCoy;SE Rivkin;HM Gross;ME Conrad;JL Abbruzzese Proc of the American Society of Clinical Oncology 23:315 (4012)