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

NCT00030641 | Unknown Phase 2

• 4 other identifiers: CDR0000069185GENTA-GN304NCI-G01-2046UCLA-0301058
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 44

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

oblimersen sodium BIOLOGICAL

docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Genta Incorporated: lead
• National Cancer Institute (NCI): collaborator

Study Sites (44)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Montgomery Cancer Center

Montgomery, Alabama, 36106-2801, United States

Location

Little Rock Hematology-Oncology Associates

Little Rock, Arkansas, 72205, United States

Location

East Bay Medical Oncology

Concord, California, 94520, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

Pacific Hematology/Oncology

San Francisco, California, 94115, United States

Location

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

Location

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

Aurora, Colorado, 80010, United States

Location

Whittingham Cancer Center

Norwalk, Connecticut, 06856, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Georgia Cancer Specialists - Northside Office

Atlanta, Georgia, 30342, United States

Location

Augusta Oncology Associates

Augusta, Georgia, 30901, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Hematology Oncology Services

New Orleans, Louisiana, 70115, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199, United States

Location

Summit Medical Group, P.A.

Summit, New Jersey, 07901, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

North General Hospital

New York, New York, 10035, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012-2510, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Harold Simmons Cancer Center

Dallas, Texas, 75390-8852, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Texas Cancer Care

Weatherford, Texas, 76086, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5048, United States

Location

Yakima Regional Cancer Care Center

Yakima, Washington, 98902, United States

Location

Morgantown Internal Medicine Group

Morgantown, West Virginia, 26505, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9162, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Medical Radiological Research Center RAMS

Kaluga Region, 249020, Russia

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

P.A. Hertzen Research Oncology Institute

Moscow, 125284, Russia

Location

Municipal Oncological Dispensary

Saint Petersburg, 197022, Russia

Location

Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

oblimersen; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Deborah Braccia

  Genta Incorporated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Last Updated: January 6, 2014

Record last verified: 2003-09

Locations

CA (4); RU (5); US (35)