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:	Cancer and Leukemia Group B
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: G3139 Drug: carboplatin Drug: etoposide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
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 Cancer and Leukemia Group B:

Primary Outcome Measures:

Survival time [ Designated as safety issue: No ]

Enrollment:	63
Study Start Date:	April 2003
Study Completion Date:	February 2008
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Std care + G3139	Biological: G3139 Drug: carboplatin Drug: etoposide
Active Comparator: Std Care	Drug: carboplatin Drug: etoposide

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

Show 47 Study Locations

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.

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00042978 History of Changes
Other Study ID Numbers:	CDR0000069489, U10CA031946, CALGB-30103
Study First Received:	August 5, 2002
Last Updated:	March 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic

Bronchial Neoplasms
Etoposide
Etoposide phosphate
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012