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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030641
Recruitment Status : Unknown
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: oblimersen sodium Drug: docetaxel Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030641


Locations
Show Show 44 study locations
Sponsors and Collaborators
Genta Incorporated
National Cancer Institute (NCI)
Investigators
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Study Chair: Deborah Braccia Genta Incorporated

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ClinicalTrials.gov Identifier: NCT00030641    
Other Study ID Numbers: CDR0000069185
GENTA-GN304
NCI-G01-2046
UCLA-0301058
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: September 2003
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:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Oblimersen
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action