BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)

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)