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

Clinical trial: Combination Chemotherapy Plus Radiation Therapy 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. Combining radiation therapy with chemotherapy may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
  -  Determine the toxicity of this regimen in these patients.
  -  Determine the quality of life of patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
  Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.
  Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
  PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed unresectable adenocarcinoma of the pancreas
  -  No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
  -  Prior subtotal resection or gross residual disease
  -  No microscopic residual disease only
  -  No metastatic disease outside of planned study radiotherapy field
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 2 times upper limit of normal (ULN)
  -  AST no greater than 3 times ULN
  Renal:
  -  Creatinine no greater than 1.5 times ULN
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Able to maintain adequate oral nutrition
  -  No significant infection
  -  No other medical condition that would preclude study
  -  No other malignancy within the past 5 years except non-melanoma skin cancer
  -  No significant nausea or vomiting
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior or concurrent biologic therapy
  Chemotherapy:
  -  No prior chemotherapy
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  No prior radiotherapy that would overlap planned study radiotherapy fields
  Surgery:
  -  See Disease Characteristics
  -  At least 21 days since prior laparotomy

Relevance to patient case: not relevant