|
TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer Clinical research trials and TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer. TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer  TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer
TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as TLK286 and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of combining TLK286 with docetaxel in treating patients who have stage IIIB or stage IV non-small cell lung cancer that is resistant to platinum-based chemotherapy (such as carboplatin or cisplatin).
Details: OBJECTIVES: Primary - Determine the safety of TLK286 and docetaxel in patients with stage IIIB or IV platinum-resistant non-small cell lung cancer. - Determine the maximum tolerated dose of TLK286 when administered with docetaxel in these patients. Secondary - Determine the pharmacokinetics of this regimen in these patients. - Determine the objective response rate of patients treated with this regimen. - Determine the duration of objective response in patients treated with this regimen. - Determine the disease stabilization rate in patients treated with this regimen. - Determine the time to tumor progression in patients treated with this regimen. OUTLINE: This is an open-label, multicenter, dose-escalation study of TLK286. Patients receive TLK286 IV over 30 minutes and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of TLK286 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients receive treatment at the MTD. Patients are followed at approximately 21 days and then every 3 months. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically (by bronchoalveolar lavage) confirmed stage IIIB or IV non-small cell lung cancer, including any of the following cellular subtypes: - Squamous cell carcinoma - Undifferentiated carcinoma - Adenocarcinoma - Mixed (adenocarcinoma with squamous cell carcinoma) - Bronchoalveolar carcinoma - Large cell carcinoma - No mixed tumors containing small cell lung carcinoma elements - Not eligible for combined chemotherapy and radiotherapy - Measurable disease - Disease progression during or after first-line therapy with platinum-containing regimens in the advanced or metastatic treatment setting - One prior cytostatic regimen (e.g., gefitinib) administered as a single agent or in combination with first-line therapy allowed - No known leptomeningeal metastases or carcinomatous meningitis - CNS metastases allowed provided all of the following are true: - Previously treated with surgery or radiotherapy - Neurologically stable - No requirement for oral or IV corticosteroids or anticonvulsants PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - ALT no greater than 3 times upper limit of normal (ULN) (no greater than 1.5 times ULN if alkaline phosphatase is greater than 2.5 times ULN) - Bilirubin no greater than ULN Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min - No evidence of gross hematuria Cardiovascular - No uncontrolled cardiac arrhythmia - No myocardial infarction within the past 6 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study therapy - No other severe, concurrent disease, infection, or comorbidity that would preclude study participation - No other malignancy within the past 2 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No psychiatric disorder that would preclude giving informed consent or study participation - No known severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 - No unstable medical conditions PRIOR CONCURRENT THERAPY: Biologic therapy - More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) - More than 3 weeks since prior immunotherapy - No concurrent routine G-CSF or GM-CSF - No concurrent biological response modifiers Chemotherapy - See Disease Characteristics - No prior docetaxel - No prior TLK286 - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent hormonal agents (except hormone replacement therapy) Radiotherapy - See Disease Characteristics - No prior whole pelvis radiotherapy - More than 3 weeks since prior radiotherapy - More than 3 weeks since prior radiopharmaceuticals - No concurrent radiotherapy, including palliative radiotherapy - Concurrent local radiotherapy allowed for pain control (i.e., bone metastases provided the field does not encompass exposure to the bladder) or brain metastases provided disease is not progressing systemically Surgery - See Disease Characteristics - More than 4 weeks since prior major surgery and recovered Other - Recovered from all prior therapy - No more than 1 prior cytotoxic therapy regimen - More than 3 weeks since prior investigational study drugs - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertFiglin, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-5907
United States
Additional Information:
Study ID Numbers: CDR0000327816; UCLA-030205101,TLK-286.2012
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068705
Other Non-Small Cell Lung Cancer Studies:
1. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
2. Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
3. Iressa/Docetaxel in Non-Small-Cell Lung Cancer
4. A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
5. Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
TLK286 and Docetaxel in Treating Patients With Stage IIIB or Stage IV Platinum-Resistant Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
