BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: ixabepilone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer |
| Study Start Date: | July 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Show 95 Study Locations| Study Chair: | Robert P. Whitehead, MD | University of Texas |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00016965 History of Changes |
| Other Study ID Numbers: | CDR0000068636, SWOG-S0107 |
| Study First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013