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

Clinical trial: Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
  PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and filgrastim (G-CSF) in patients with advanced solid tumors.
  -  Determine the dose-limiting toxicity associated with this regimen in these patients.
  -  Assess the objective anti-tumor response in patients treated with this regimen.
  -  Determine fatigue and blood cytokines in patients treated with this regimen.
  OUTLINE: This is a dose-escalation study of docetaxel.
  Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 2 and continuing until blood counts recover. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  Fatigue is assessed at baseline and then at weeks 2, 5, 7, and 9 during therapy.
  PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 15-22 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed advanced solid tumor that is not curable by surgery or radiotherapy
  -  Sarcoma
  -  Melanoma
  -  Carcinoma of unknown primary
  -  Pancreatic cancer
  -  Lung cancer
  -  Ovarian cancer
  -  Breast cancer
  -  Bladder cancer
  -  Gastric cancer
  -  Esophageal cancer
  -  Prostate cancer
  -  Head and neck cancer
  -  No hematopoietic or lymphoid tumors
  -  Measurable or evaluable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  Karnofsky 60-100%
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Bilirubin normal
  -  AST and/or ALT no greater than 5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR
  -  Alkaline phosphatase no greater than 5 times ULN if AST and ALT no greater than ULN OR
  -  AST and/or ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than 2.5 times ULN
  Renal:
  -  Creatinine no greater than 2 times ULN OR
  -  Creatinine clearance at least 50 mL/min
  Cardiovascular:
  -  No congestive heart failure
  -  No unstable angina
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No uncontrolled infection
  -  No known sensitivity to E. coli-derived products
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 2 weeks since prior cytotoxic anti-tumor therapy (4 weeks for nitrosourea or mitomycin) and recovered
  -  No prior docetaxel or gemcitabine
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 2 weeks since prior radiotherapy and recovered
  Surgery:
  -  Not specified

Relevance to patient case: not relevant