Docetaxel in Treating Patients With Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Breast Cancer Head and Neck Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients |
| Enrollment: | 109 |
| Study Start Date: | September 1998 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: Approximately 80 patients (40 Caucasian and 40 African American) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- 0-2
Life expectancy:
- Not specified
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
Contacts and Locations
Show 74 Study Locations| Study Chair: | Lionel D. Lewis, MD | Norris Cotton Cancer Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00003565 History of Changes |
| Other Study ID Numbers: | CDR0000066631, U10CA031946, CLB-9871 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer stage III bladder cancer recurrent bladder cancer stage IV bladder cancer stage IV nasopharyngeal cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary pulmonary carcinoid tumor stage III squamous cell carcinoma of the lip and oral cavity stage III basal cell carcinoma of the lip stage III verrucous carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Breast Neoplasms Head and Neck Neoplasms Lung Neoplasms Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases |
Breast Diseases Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013