Combination Chemotherapy With or Without Oblimersen in Treating Patients With Extensive-Stage Small Cell Lung Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042978

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Oblimersen may increase the effectiveness of carboplatin and etoposide by making tumor cells more sensitive to the drugs.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without oblimersen in treating patients who have extensive-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Biological: oblimersen sodium Drug: carboplatin Drug: etoposide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 (NSC #683428, IND #58842) In Patients With Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etoposide Carboplatin Etoposide phosphate Oblimersen sodium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival time [ Designated as safety issue: No ]

Study Start Date:	April 2003
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the percentage of patients with extensive stage small cell lung cancer who live longer than 12 months after receiving treatment with carboplatin and etoposide with or without oblimersen.
Compare the response rate of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oblimersen IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8.
Arm II: Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 1 hour on days 1-3.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients (41 for arm I and 14 for arm II) will be accrued for this study within 11 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) for which combination modality therapy with chemotherapy and radiotherapy is not being considered
No active CNS metastases
- Patients with CNS metastases are eligible if they have completed a course of CNS radiotherapy, if clinically indicated

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic

Bilirubin normal
AST no greater than 2.5 times upper limit of normal (ULN)
PT and PTT no greater than 1.5 times ULN

Renal

Creatinine no greater than 2 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular

No cardiac disease that would preclude study

Other

HIV negative
No other concurrent medical conditions that would preclude study
No uncontrolled infection
No psychiatric illness that would preclude informed consent
No uncontrolled diabetes mellitus
No other concurrent active malignancy except nonmelanoma skin cancer
- Patients are not considered to have a currently active malignancy if they have completed therapy and have less than a 30% risk of relapse
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No prior chemotherapy for SCLC
No other concurrent chemotherapy

Endocrine therapy

No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

See Disease Characteristics
At least 1 week since prior radiotherapy and recovered
Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
No concurrent palliative radiotherapy

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042978

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Locations

United States, California
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0843
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
La Grange Oncology Associates
La Grange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States, 08103
United States, New York
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Mount Sinai Medical Center
New York, New York, United States, 10029
North Shore University Hospital
Manhasset, New York, United States, 11030
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28503-1678
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805-9913
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Miriam Hospital at Lifespan
Providence, Rhode Island, United States, 02906
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States, 24014
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Ravi Salgia, MD, PhD

University of Chicago

More Information

Additional Information:

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

Publications:

Rudin CM, Salgia R, Wang X, Hodgson LD, Masters GA, Green M, Vokes EE. Randomized phase II Study of carboplatin and etoposide with or without the bcl-2 antisense oligonucleotide oblimersen for extensive-stage small-cell lung cancer: CALGB 30103. J Clin Oncol. 2008 Feb 20;26(6):870-6.

Rudin CM, Salgia R, Wang XF, et al.: CALGB 30103: a randomized phase II study of carboplatin and etoposide (CE) with or without G3139 in patients with extensive stage small cell lung cancer (ES-SCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7168, 662s, 2005.

Study ID Numbers:	CDR0000069489, CALGB-30103
Study First Received:	August 5, 2002
Last Updated:	April 4, 2009
ClinicalTrials.gov Identifier:	NCT00042978 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carboplatin
Etoposide phosphate
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009