Docetaxel in Treating Patients With Solid Tumors

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Bladder Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Lung Cancer; Head and Neck Cancer

Treatments: Drug: docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003565

CDR0000066631 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

CALGB-9871

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

docetaxel

Experimental group

Description:

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.

Treatment:

Drug: docetaxel