A Phase 1 interventional study of oblimersen sodium and carboplatin in Extensive Stage Small Cell Lung Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer.
II. Determine the toxicity and feasibility of this regimen in these patients. III. Determine potential antitumor activity of this regimen as assessed by objective response in these patients.
OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of G3139 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-12 patients will be accrued for this study within 5 months.
National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.
Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.
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Inclusion Criteria:
No active CNS disease
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
Biological: oblimersen sodium · Drug: carboplatin · Drug: etoposide · Other: pharmacological study · Other: laboratory biomarker analysis
Given IV
Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: EPEG, VP-16, VP-16-213
Correlative studies
Also known as: pharmacological studies
Correlative studies
Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
Data will be summarized separately for each dose level, by severity, and type of toxicity.
Time frame: Up to 3 years
Maximally tolerated dose of oblimersen sodium
Time frame: 8 days
Potential antitumor activity (responses to therapy)
Will be analyzed using simple descriptive statistics only.
Time frame: Up to 3 years
Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level
Will be analyzed using a paired t-test. If there are outliers or the distribution of changes in oblimersen sodium levels appears to be highly non-normal, the data will be analyzed using the Wilcoxon singed-rank test.
Time frame: Day 6 and 8
The record gives a start of Apr 2001 and a primary completion of Jan 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Oblimersen · Carboplatin · Etoposide
National Cancer Institute (NCI) →