Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Ravi Salgia

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00042978
Information obtained from ClinicalTrials.gov on December 14, 2011

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