BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: ixabepilone

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00016965

SWOG-S0107

CDR0000068636

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)