NCT00016965

BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

Official Title:

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

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.

Eligibility

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)

Disease(s) and\or Condition(s)

Pancreatic Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: ixabepilone
    • Description:
    • Arm Group Labels:
Sponsor
  • SWOG Cancer Research Network