Lung CancerPhase 2/3NCT00030641
Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
A Phase 2/3 study testing oblimersen sodium and docetaxel in people with Lung Cancer, run by Genta Incorporated at 44 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- oblimersen sodium and docetaxel
- How many people
- Not given
- Where
- 44 sitesin 3 countries
- Study dates
- Oct 2001to not given
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
44 sites in 3 countries.
44 sites in 3 countries
United States35 sites
Arlington Cancer Center
Arlington, Texas, 76012-2510
Georgia Cancer Specialists - Northside Office
Atlanta, Georgia, 30342
Augusta Oncology Associates
Augusta, Georgia, 30901
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Charleston Cancer Center
Charleston, South Carolina, 29406
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
East Bay Medical Oncology
Concord, California, 94520
Medical City Dallas Hospital
Dallas, Texas, 75230
Harold Simmons Cancer Center
Dallas, Texas, 75390-8852
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Central Baptist Hospital
Lexington, Kentucky, 40503
Little Rock Hematology-Oncology Associates
Little Rock, Arkansas, 72205
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
Winthrop University Hospital
Mineola, New York, 11501
Montgomery Cancer Center
Montgomery, Alabama, 36106-2801
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162
Hematology Oncology Services
New Orleans, Louisiana, 70115
North General Hospital
New York, New York, 10035
Whittingham Cancer Center
Norwalk, Connecticut, 06856
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
Medical Oncology Care Associates
Orange, California, 92868
Pacific Hematology/Oncology
San Francisco, California, 94115
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, 90404
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Summit Medical Group, P.A.
Summit, New Jersey, 07901
Madigan Army Medical Center
Tacoma, Washington, 98431-5048
Texas Cancer Care
Weatherford, Texas, 76086
Yakima Regional Cancer Care Center
Yakima, Washington, 98902
Russia5 sites
Medical Radiological Research Center RAMS
Kaluga Region, 249020
Russian Academy of Medical Sciences Cancer Research Center
Moscow, 115478
P.A. Hertzen Research Oncology Institute
Moscow, 125284
Municipal Oncological Dispensary
Saint Petersburg, 197022
Petrov Research Institute of Oncology
Saint Petersburg, 197758
Canada4 sites
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
McGill University
Montreal, Quebec, H2W 1S6
L'Hopital Laval
Ste-Foy, Quebec, G1V 4G5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- oblimersen sodium, docetaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oblimersen sodiumBiological
docetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Deborah Braccia, Study chair, Genta Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030641
- Sponsor's protocol ID
- CDR0000069185
- Other IDs
- GENTA-GN304, NCI-G01-2046, UCLA-0301058
- Status last verified
- Sep 2003
- First submitted
- 14 Feb 2002
- Last updated
- 6 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00030641
- Acronym / sponsor ID
- CDR0000069185
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oblimersen sodium | Biological | – |
| docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Braccia study chair
Genta Incorporated
44 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing oblimersen sodium and docetaxel in people with Lung Cancer, run by Genta Incorporated at 44 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Russia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.