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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Deborah Braccia

Investigator Role:

Study Chair

Investigator Affiliation:

Genta Incorporated

Authority:

United States: Federal Government

Study ID:

CDR0000069185

NCT ID:

NCT00030641

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Medical City Dallas HospitalDallas, Texas  75230
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Whittingham Cancer CenterNorwalk, Connecticut  06856
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Madigan Army Medical CenterTacoma, Washington  98431-5048
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winthrop University HospitalMineola, New York  11501
Central Baptist HospitalLexington, Kentucky  40503
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
Arlington Cancer CenterArlington, Texas  76012
John Wayne Cancer Institute at Saint John's Health CenterSanta Monica, California  90404
Yakima Regional Cancer Care CenterYakima, Washington  89802
Texas Cancer CareFort Worth, Texas  76104
Pacific Hematology/OncologySan Francisco, California  94115
Montgomery Cancer CenterMontgomery, Alabama  36106-3657
Morgantown Internal Medicine GroupMorgantown, West Virginia  26505
Little Rock Hematology-Oncology AssociatesLittle Rock, Arkansas  72205
Medical Oncology Care AssociatesOrange, California  92668
Georgia Cancer Specialists - Northside OfficeAtlanta, Georgia  30342
Summit Medical Group, P.A.Summit, New Jersey  07901
East Bay Medical OncologyConcord, California  94520
Lakeland Regional Cancer CenterLakeland, Florida  33805
Augusta Oncology AssociatesAugusta, Georgia  30901
Hematology Oncology ServicesNew Orleans, Louisiana  70115
North General HospitalNew York, New York  10035
Charleston Cancer CenterCharleston, South Carolina  29406
Harold Simmons Cancer CenterDallas, Texas  75390-8852