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.
Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northeast Alabama Regional Medical CenterAnniston, Alabama
- Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
- Veterans Affairs Medical Center - San DiegoSan Diego, California
- UCSF Comprehensive Cancer CenterSan Francisco, California
- Veterans Affairs Medical Center - San FranciscoSan Francisco, California
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Lombardi Cancer CenterWashington D.C., District of Columbia
- Walter Reed Army Medical CenterWashington D.C., District of Columbia
- Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
- Broward General Medical CenterFort Lauderdale, Florida
- Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.