Docetaxel in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

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