Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Docetaxel in Treating Patients With Solid Tumors

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 compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.

Detailed description: OBJECTIVES:
  -  Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors.
  -  Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations.
  -  Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations.
  OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven unresectable solid tumors (e.g., lung, breast, head and neck, bladder)
  -  Clinically suitable for treatment with single agent docetaxel
  -  Caucasian (at least 2 generations originating in any of the original peoples of Europe, North Africa, or the Middle East) OR
  -  African American (at least 2 generations originating in any of the black racial groups of Africa)
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  0-2
  Hematopoietic:
  -  Granulocyte count at least 1,500/mm3
  -  Platelet count at least 100,000/mm3
  Hepatic:
  -  Bilirubin no greater than upper limit of normal (ULN)
  -  AST no greater than 1.5 times ULN AND
  -  Alkaline phosphatase no greater than 2.5 times ULN
  Renal:
  -  BUN no greater than 1.5 times ULN
  -  Creatinine no greater 1.5 times ULN
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior bone marrow transplantation
  Chemotherapy:
  -  No prior docetaxel
  -  Prior paclitaxel allowed
  -  1 or 2 prior chemotherapy regimens allowed
  -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  No concurrent hormones for disease related conditions
  -  Concurrent steroids for adrenal failure allowed
  Radiotherapy:
  -  At least 2 weeks since prior radiotherapy
  -  Palliative radiotherapy allowed except whole brain irradiation for CNS disease
  Surgery:
  -  Not specified
  Other:
  -  At least 48 hours since prior or concurrent ethanol (CYP3A enzyme inducer) or grapefruit juice (CYP3A enzyme inhibitor)
  -  At least 7 days since prior or concurrent CYP450 inducing drugs:
  -  Antiseizure medications: phenobarbital, phenytoin, carbamazepine, or lamotrigine
  -  Anti-TB therapy: rifampin, isoniazid, or sulfinpyrazone
  -  At least 7 days since prior or concurrent CYP450 3A inhibiting drugs:
  -  Macrolides: erythromycin, clarithromycin, azithromycin, or roxithromycin
  -  Azoles: ketoconazole, fluconazole, or itraconazole
  -  Other antibiotics: metronidazole or chloramphenicol
  -  Anti-HIV drugs: ritonavir, indinavir, nelfinavir, or delavirdine
  -  Immunosuppressive agents: cyclosporine
  -  Antidepressant agent: nefazodone

Relevance to patient case: not relevant