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

January 3, 2014 updated by: Genta Incorporated

Randomized Study of Docetaxel Versus Docetaxel Plus Genasense™ (G3139; Bcl-2 Antisense Oligonucleotide) in Patients With Previously Treated Non-Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Deborah Braccia, Genta Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069185
  • GENTA-GN304
  • NCI-G01-2046
  • UCLA-0301058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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