Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-30103 NCT00042978

Objectives

1. 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.
2. Compare the response rate of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.

Entry 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

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

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

Expected Enrollment

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

Outcomes

Survival time

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.

Rudin CM, Salgia R, Wang X, et al.: 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 26 (6): 870-6, 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Ravi Salgia, MD, PhD, Protocol chair		Ph: 773-702-4399; 888-824-0200 Email: rsalgia@medicine.bsd.uchicago.edu

Registry Information
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
Trial Start Date		2003-04-15
Trial Completion Date		2008-02-20
Registered in ClinicalTrials.gov		NCT00042978
Date Submitted to PDQ		2002-06-11
Information Last Verified		2005-11-01
NCI Grant/Contract Number		CA31946

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