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Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Genta Incorporated
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
Drug: docetaxel
Drug: oblimersen
Phase II
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Docetaxel Oblimersen sodium
U.S. FDA Resources
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

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

  Show 44 Study Locations
Sponsors and Collaborators
Genta Incorporated
Investigators
Study Chair: Deborah Braccia Genta Incorporated
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069185, GENTA-GN304, NCI-G01-2046, UCLA-0301058
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030641  
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

Study placed in the following topic categories:
Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009