Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: BMS-247550 in Treating Patients With Advanced Pancreatic 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.

Detailed 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.

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)

Relevance to patient case: not relevant