Full Text View
Tabular View
No Study Results Posted
Related Studies
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: February 14, 2002   Last Updated: April 4, 2009   History of Changes
Sponsor: Genta Incorporated
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030641
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: oblimersen sodium
Drug: docetaxel
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030641

  Hide Study Locations
Locations
United States, Alabama
Montgomery Cancer Center
Montgomery, Alabama, United States, 36106-2801
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arkansas
Little Rock Hematology-Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
East Bay Medical Oncology
Concord, California, United States, 94520
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
Medical Oncology Care Associates
Orange, California, United States, 92868
Pacific Hematology/Oncology
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Connecticut
Whittingham Cancer Center
Norwalk, Connecticut, United States, 06856
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
United States, Georgia
Augusta Oncology Associates
Augusta, Georgia, United States, 30901
Georgia Cancer Specialists - Northside Office
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Louisiana
Hematology Oncology Services
New Orleans, Louisiana, United States, 70115
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Jersey
Summit Medical Group, P.A.
Summit, New Jersey, United States, 07901
United States, New York
North General Hospital
New York, New York, United States, 10035
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, Oklahoma
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012-2510
Harold Simmons Cancer Center
Dallas, Texas, United States, 75390-8852
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Texas Cancer Care
Weatherford, Texas, United States, 76086
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5048
Yakima Regional Cancer Care Center
Yakima, Washington, United States, 98902
United States, West Virginia
Morgantown Internal Medicine Group
Morgantown, West Virginia, United States, 26505
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9162
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
McGill University
Montreal, Quebec, Canada, H2W 1S6
Russian Federation
Russian Academy of Medical Sciences Cancer Research Center
Moscow, Russian Federation, 115478
Municipal Oncological Dispensary
Saint Petersburg, Russian Federation, 197022
P.A. Hertzen Research Oncology Institute
Moscow, Russian Federation, 125284
Petrov Research Institute of Oncology
Saint Petersburg, Russian Federation, 197758
Medical Radiological Research Center RAMS
Kaluga Region, Russian Federation, 249020
Sponsors and Collaborators
Genta Incorporated
Investigators
Study Chair: Deborah Braccia Genta Incorporated
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069185, GENTA-GN304, NCI-G01-2046, UCLA-0301058
Study First Received: February 14, 2002
Last Updated: April 4, 2009
ClinicalTrials.gov Identifier: NCT00030641     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009