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

NCT ID: NCT00030641

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oblimersen sodium

Intervention Type: BIOLOGICAL

docetaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Principal Investigators

Deborah Braccia

Role: STUDY_CHAIR

Genta Incorporated

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Montgomery Cancer Center

Montgomery, Alabama, United States

Little Rock Hematology-Oncology Associates

Little Rock, Arkansas, United States

East Bay Medical Oncology

Concord, California, United States

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Medical Oncology Care Associates

Orange, California, United States

Pacific Hematology/Oncology

San Francisco, California, United States

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, United States

Whittingham Cancer Center

Norwalk, Connecticut, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Georgia Cancer Specialists - Northside Office

Atlanta, Georgia, United States

Augusta Oncology Associates

Augusta, Georgia, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Hematology Oncology Services

New Orleans, Louisiana, United States

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, United States

Summit Medical Group, P.A.

Summit, New Jersey, United States

Winthrop University Hospital

Mineola, New York, United States

North General Hospital

New York, New York, United States

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, United States

Charleston Cancer Center

Charleston, South Carolina, United States

Arlington Cancer Center

Arlington, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Harold Simmons Cancer Center

Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Texas Cancer Care

Weatherford, Texas, United States

Madigan Army Medical Center

Tacoma, Washington, United States

Yakima Regional Cancer Care Center

Yakima, Washington, United States

Morgantown Internal Medicine Group

Morgantown, West Virginia, United States

West Virginia University Hospitals

Morgantown, West Virginia, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

McGill University

Montreal, Quebec, Canada

L'Hopital Laval

Ste-Foy, Quebec, Canada

Medical Radiological Research Center RAMS

Kaluga Region, , Russia

Russian Academy of Medical Sciences Cancer Research Center

Moscow, , Russia

P.A. Hertzen Research Oncology Institute

Moscow, , Russia

Municipal Oncological Dispensary

Saint Petersburg, , Russia

Petrov Research Institute of Oncology

Saint Petersburg, , Russia

Countries

United States; Canada; Russia

Other Identifiers

GENTA-GN304

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2046

Identifier Type: -

Identifier Source: secondary_id

UCLA-0301058

Identifier Type: -

Identifier Source: secondary_id

CDR0000069185

Identifier Type: -

Identifier Source: org_study_id