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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United States

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

Other trials in Russia

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

Other trials in Canada

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001

Resources

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)
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

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.

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