|
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer Clinical research trials and Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer  Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractorystage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: Primary - Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel. Secondary - Compare time to progression in patients treated with these regimens. - Compare the overall and 1-year survival of patients treated with these regimens. - Compare the safety and tolerability of these regimens in these patients. - Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. - Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR. Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment. Patients are followed at 30 days and then every 3 months for survival. PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) 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 confirmed non-small cell lung cancer - Locally advanced (stage IIIB) or metastatic (stage IV) disease - Inoperable disease - Relapsed or refractory disease - Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease - Measurable or evaluable disease - No symptomatic or inadequately treated brain metastases - No CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 3 months Hematopoietic - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 8.0 g/dL - Absolute neutrophil count greater than 1,500/mm^3 Hepatic - AST and ALT less than 3 times upper limit of normal (ULN) - Bilirubin less than 1.5 times ULN - Hepatitis B surface antigen negative - Hepatitis C negative Renal - Creatinine less than 1.8 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart failure - No uncontrolled angina - No severe uncontrolled ventricular arrhythmias - No electrocardiographic evidence of acute ischemia or active conduction system abnormalities - No poorly controlled hypertension Immunologic - No active systemic infection requiring treatment - No prior allergic reaction attributable to compounds containing boron or mannitol - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No peripheral neuropathy grade 2 or greater - No diabetes mellitus - No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - More than 6 weeks since prior monoclonal antibody therapy - No concurrent routine use of colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy - No prior docetaxel - Prior paclitaxel allowed - No other concurrent chemotherapy Endocrine therapy - No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - More than 4 weeks since prior major surgery - No concurrent surgery for cancer management or treatment Other - More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix - More than 4 weeks since prior investigational agents - No prior bortezomib - No other concurrent investigational agents - No other concurrent clinical research study participation - No other concurrent antineoplastic therapy - No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanSchiller, Principal Investigator, University of Wisconsin Comprehensive Cancer Center
Blumenthal Cancer Center at Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28232-2861
United States
Recruiting Darlene Durban 704-355-8289
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-5666
United States
Recruiting Lana Hammes 608-262-8126
Hubert H. Humphrey Cancer Center at North Memorial Medical Center *Recruiting*
Robbinsdale, Minnesota, 55422
United States
Recruiting Nancy Sundeen 763-520-5847
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Karen Yusuf 404-321-6111 ext. 7899
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Louis Toles 314-454-8557
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Pat Ostler 617-724-7829
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Lyn Magree 720-848-0676
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Rainell Schaerer 713-745-5912
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Virginia Naessig 310-423-0721
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Rita Gerard 801-585-0550
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Deborah Scott 215-503-5641
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Janelle Bowersox 404-778-5959
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Leslie Bilodeau 314-577-8854
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8028
United States
Recruiting Marianne Davies 203-737-1600
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Paulette Baldie 305-243-4180
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6868
United States
Recruiting Valerie Kordowski 615-936-3879
Kansas City Cancer Centers - Central *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Kirstin Fink 816-960-6048
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Cheryl Elzinga 310-206-8106
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35233-2115
United States
Recruiting Karen Harper 205-934-5092
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Joan Lucca 617-632-5403
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Karen Padilla 919-681-4768
Additional Information:
Study ID Numbers: CDR0000305974; WCCC-M34102-048,MILLENNIUM-M34102-048,UCLA-0301037
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064012
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
2. Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
4. Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
5. Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
|
|
|
|
|
|
|
|
