Docetaxel in Treating Patients With Solid Tumors

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.

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 Criteria:
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