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Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
oblimersen sodium
docetaxel
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Montgomery Cancer Center
  • Little Rock Hematology-Oncology Associates
  • East Bay Medical Oncology
  • Jonsson Comprehensive Cancer Center, UCLA
  • Medical Oncology Care Associates
  • Pacific Hematology/Oncology
  • John Wayne Cancer Institute at Saint John's Health Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Whittingham Cancer Center
  • Lakeland Regional Cancer Center
  • Georgia Cancer Specialists - Northside Office
  • Augusta Oncology Associates
  • University of Chicago Cancer Research Center
  • CCOP - Northern Indiana CR Consortium
  • Central Baptist Hospital
  • Hematology Oncology Services
  • Louisiana State University Health Sciences Center - Shreveport
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
  • Summit Medical Group, P.A.
  • Winthrop University Hospital
  • North General Hospital
  • Veterans Affairs Medical Center - Oklahoma City
  • Charleston Cancer Center
  • Arlington Cancer Center
  • Medical City Dallas Hospital
  • Harold Simmons Cancer Center
  • University of Texas - MD Anderson Cancer Center
  • Joe Arrington Cancer Research and Treatment Center
  • Texas Cancer Care
  • Madigan Army Medical Center
  • Yakima Regional Cancer Care Center
  • Morgantown Internal Medicine Group
  • West Virginia University Hospitals
  • Princess Margaret Hospital
  • Hopital Charles Lemoyne
  • McGill University
  • L'Hopital Laval
  • Medical Radiological Research Center RAMS
  • Russian Academy of Medical Sciences Cancer Research Center
  • P.A. Hertzen Research Oncology Institute
  • Municipal Oncological Dispensary
  • Petrov Research Institute of Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
January 3, 2014
Sponsor
Genta Incorporated
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030641
Brief Title
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
Official Title
Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genta Incorporated
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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: Randomized phase 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Braccia
Organizational Affiliation
Genta Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Montgomery Cancer Center
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106-2801
Country
United States
Facility Name
Little Rock Hematology-Oncology Associates
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
East Bay Medical Oncology
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Hematology/Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
John Wayne Cancer Institute at Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Whittingham Cancer Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Georgia Cancer Specialists - Northside Office
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Augusta Oncology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Hematology Oncology Services
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
Summit Medical Group, P.A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
North General Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Facility Name
Veterans Affairs Medical Center - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012-2510
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Harold Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8852
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Texas Cancer Care
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5048
Country
United States
Facility Name
Yakima Regional Cancer Care Center
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Morgantown Internal Medicine Group
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
L'Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Medical Radiological Research Center RAMS
City
Kaluga Region
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
P.A. Hertzen Research Oncology Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Municipal Oncological Dispensary
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Petrov Research Institute of Oncology
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

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