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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00030641
• Other study ID #: CDR0000069185
• Secondary ID: GENTA-GN304NCI-G
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 14, 2002
• Last updated: January 3, 2014
• Start date: October 2001

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• oblimersen sodium

Drug:
• docetaxel

Locations

Country	Name	City	State
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	McGill University	Montreal	Quebec
Canada	L'Hopital Laval	Ste-Foy	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Russian Federation	Medical Radiological Research Center RAMS	Kaluga Region
Russian Federation	P.A. Hertzen Research Oncology Institute	Moscow
Russian Federation	Russian Academy of Medical Sciences Cancer Research Center	Moscow
Russian Federation	Municipal Oncological Dispensary	Saint Petersburg
Russian Federation	Petrov Research Institute of Oncology	Saint Petersburg
United States	Arlington Cancer Center	Arlington	Texas
United States	Georgia Cancer Specialists - Northside Office	Atlanta	Georgia
United States	Augusta Oncology Associates	Augusta	Georgia
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Charleston Cancer Center	Charleston	South Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	East Bay Medical Oncology	Concord	California
United States	Harold Simmons Cancer Center	Dallas	Texas
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Little Rock Hematology-Oncology Associates	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Winthrop University Hospital	Mineola	New York
United States	Montgomery Cancer Center	Montgomery	Alabama
United States	Morgantown Internal Medicine Group	Morgantown	West Virginia
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Hematology Oncology Services	New Orleans	Louisiana
United States	North General Hospital	New York	New York
United States	Whittingham Cancer Center	Norwalk	Connecticut
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
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	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Summit Medical Group, P.A.	Summit	New Jersey
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Texas Cancer Care	Weatherford	Texas
United States	Yakima Regional Cancer Care Center	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Genta Incorporated	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation,