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Home > "D" Clinical Trials Conditions > Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer  Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Genta , 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. Oblimersen may increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if docetaxel is more effective with or without oblimersen in treating non-small cell lung cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated.
Details: OBJECTIVES: - Compare the survival of patients with non-small cell lung cancer treated with docetaxel with or without oblimersen (G3139). - Compare the proportion of major antitumor responses in patients treated with these regimens. - Compare the response duration and time to progression in patients treated with these regimens. - Compare the safety and clinical benefit of these regimens, in terms of changes in performance status and tumor-related symptoms, in these patients. - Compare the proportion of patients surviving 6 and 12 months after treatment with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to response to prior first-line chemotherapy regimen (progression vs stable disease, partial response, or complete response), ECOG performance status (0-1 vs 2), and prior paclitaxel treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oblimersen (G3139) IV continuously on days 1-7 and docetaxel IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease upon completion of 8 courses may receive 8 or more additional courses at physician's discretion. - Arm II: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Upon completion of 8 courses, patients may continue to receive docetaxel off study at physician's discretion. Patients are followed every 9 weeks for up to 18 months. PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of non-small lung cancer (NSCLC) - Stage IIIB (malignant pleural/pericardial effusion) or IV - Relapsed or refractory disease - Measurable disease that has not been irradiated - Previously treated with 1, and only 1, cytotoxic chemotherapy regimen in the neoadjuvant, adjuvant, or metastatic setting - No untreated or symptomatic brain metastases or leptomeningeal disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 (without growth factor support) - Platelet count at least 100,000/mm^3 - No bleeding or coagulation disorder Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN - Albumin at least 3.0 g/dL - PT no greater than 1.5 times ULN OR INR no greater than 1.3 - PTT no greater than 1.5 times ULN - No chronic hepatitis - No chronic cirrhosis Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease - No uncontrolled congestive heart failure Pulmonary: - No severe pulmonary disease - No requirement for oxygen due to pneumonectomy - No severe pleural effusion secondary to NSCLC Immunologic: - HIV negative - No active infection - No active autoimmune disease Other: - No other concurrent active cancer - No uncontrolled diabetes mellitus - No uncontrolled seizure disorder - No peripheral neuropathy grade 2 or greater - No active peptic ulcer disease - No other significant medical disease - No intellectual, emotional, or physical disability that would preclude study participation - No neurologic disorders, overt psychosis, mental disability, or evidence of a limited capacity to give informed consent or to comply with study treatment - No known hypersensitivity to phosphorothioate-containing oligonucleotides - No history of hypersensitivity to drugs containing the excipient Tween 80 (polysorbate 80) - Satisfactory venous access for multi-day continuous infusion - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior cytokines or vaccine therapy for NSCLC - At least 3 weeks since prior immunotherapy or biologic therapy for NSCLC - No concurrent anticancer biologic therapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy for NSCLC - No prior docetaxel - No other concurrent anticancer chemotherapy Endocrine therapy: - No concurrent corticosteroids* except for the following conditions: - CNS disease - Underlying lung disease NOTE: *Dose must be stable or decreasing for at least 4 weeks before study participation Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy for NSCLC - No prior radiotherapy to 25% or more of bone marrow (e.g., whole pelvis) - No concurrent anticancer radiotherapy Surgery: - At least 3 weeks since prior surgery for NSCLC - No prior organ allograft Other: - Recovered from prior therapy - Prior first-line epidermal growth factor receptors (EGFR) administered with cytotoxic therapy are allowed - At least 3 weeks since prior investigational drugs - At least 3 weeks since other prior therapy NSCLC - No prior anticancer therapy subsequent to the first (and only) prior cytotoxic chemotherapy regimen - No prior second-line EGFR therapy - No prior oblimersen (G3139) - No other concurrent investigational or anticancer therapies - No concurrent anticoagulation therapy except for warfarin (1 mg/day) for central line prophylaxis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahBraccia, Study Chair, Genta
Petrov Research Institute of Oncology *Recruiting*
Saint Petersburg, , 197758
Russian Federation
Recruiting Vladimir Moiseyenko 7-812-596-6523
Yakima Regional Cancer Care Center *Recruiting*
Yakima, Washington, 98902
United States
Recruiting Thomas Boyd 509-575-7615
Augusta Oncology Associates *Recruiting*
Augusta, Georgia, 30901
United States
Recruiting Mark Keaton 706-736-1830
Lakeland Regional Cancer Center *Recruiting*
Lakeland, Florida, 33805
United States
Recruiting Andrew Pippas 863-603-6565
Russian Academy of Medical Sciences Cancer Research Center *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting L. Demidov 7-095-324-1504
Pacific Hematology/Oncology *Recruiting*
San Francisco, California, 94115
United States
Recruiting Ari Baron 415-923-3012
Charleston Cancer Center *Recruiting*
Charleston, South Carolina, 29406
United States
Recruiting Bill Schmidt 843-572-9211
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Pierre Desjardins 450-466-5065
Arlington Cancer Center *Recruiting*
Arlington, Texas, 76012-2510
United States
Recruiting John Adams 817-261-4906
East Bay Medical Oncology *Recruiting*
Concord, California, 94520
United States
Recruiting Robert Robles 925-676-4740
Central Baptist Hospital *Recruiting*
Lexington, Kentucky, 40503
United States
Recruiting Lee Hicks 859-260-6065
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Wilson Miller 514-398-1444
Hematology Oncology Services *Recruiting*
New Orleans, Louisiana, 70115
United States
Recruiting Thomas Cosgriff 504-897-5869
Montgomery Cancer Center *Recruiting*
Montgomery, Alabama, 36106-2801
United States
Recruiting Stephen Davidson 334-273-7000
Texas Cancer Care *Recruiting*
Weatherford, Texas, 76086
United States
Recruiting Ray Page 817-596-0637
Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Barry Mirtsching 972-566-5588
West Virginia University Hospitals *Recruiting*
Morgantown, West Virginia, 26506-9162
United States
Recruiting John Rogers 304-293-4980
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha, Nebraska, 68114-4199
United States
Recruiting Laxmi Buddharaju 402-354-5077
Municipal Oncological Dispensary *Recruiting*
Saint Petersburg, , 197022
Russian Federation
Recruiting Gregory Manikhas 7-812-156-9900
Summit Medical Group, P.A. *Recruiting*
Summit, New Jersey, 07901
United States
Recruiting Michael Wax 908-219-3080
Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Robert Chapman 313-916-1850
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Roy Herbst 713-792-6363
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Charles Rudin 773-702-4142
John Wayne Cancer Institute at Saint John's Health Center *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Peter Boasberg 310-998-3961
Morgantown Internal Medicine Group *Recruiting*
Morgantown, West Virginia, 26505
United States
Recruiting Charles Beall 304-599-8802
Medical Oncology Care Associates *Recruiting*
Orange, California, 92868
United States
Recruiting Birbal Bhaskar 714-541-0531
Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Arafat Tfayli 405-270-1565
Joe Arrington Cancer Research and Treatment Center *Recruiting*
Lubbock, Texas, 79410-1894
United States
Recruiting Jose Figueroa 806-725-8000
L'Hopital Laval *Recruiting*
Ste Foy, Quebec, G1V 4G5
Canada
Recruiting Bruno Raby 418-656-8711
Whittingham Cancer Center *Recruiting*
Norwalk, Connecticut, 06856
United States
Recruiting Richard Frank 203-845-2067
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Karen Kelly 303-315-3561
Little Rock Hematology-Oncology Associates *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Brad Baltz 501-907-6444
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Frances Shepherd 416-946-4522
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Francisco Robert 205-934-5077
P.A. Hertzen Research Oncology Institute *Recruiting*
Moscow, , 125284
Russian Federation
Recruiting Valeriy Chissov 095-945-1935
Winthrop University Hospital *Recruiting*
Mineola, New York, 11501
United States
Recruiting Harry Staszewski 518-663-9500
Harold Simmons Cancer Center *Recruiting*
Dallas, Texas, 75390-8852
United States
Recruiting Jonathan Dowell 214-648-1933
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Glenn Mills 318-675-7639
North General Hospital *Recruiting*
New York City, New York, 10035
United States
Recruiting Jenny Romero 212-423-1583
Madigan Army Medical Center *Recruiting*
Tacoma, Washington, 98431-5048
United States
Recruiting David McCune 253-968-2505
Medical Radiological Research Center RAMS *Recruiting*
Kaluga Region, , 249020
Russian Federation
Recruiting Viktor Medvedev 7-08439-7-20-57
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Georgia Cancer Specialists - Northside Office *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Mansoor Saleh 404-256-4777
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Diane Prager 310-794-7758
Additional Information:
Study ID Numbers: CDR0000069185; GENTA-GN304,UCLA-0301058,NCI-G01-2046
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030641
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
2. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
3. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
4. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
5. Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Connecticut Clinical Trials
Other Norwalk Clinical Trials
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
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