Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00017251 |
Recruitment Status
:
Completed
First Posted
: January 27, 2003
Last Update Posted
: January 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Extensive Stage Small Cell Lung Cancer | Biological: oblimersen sodium Drug: carboplatin Drug: etoposide Other: pharmacological study Other: laboratory biomarker analysis | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer |
Study Start Date : | April 2001 |
Actual Primary Completion Date : | January 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (oblimersen sodium, carboplatin, etoposide)
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.
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Biological: oblimersen sodium
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: etoposide
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
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- Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0 [ Time Frame: Up to 3 years ]Data will be summarized separately for each dose level, by severity, and type of toxicity.
- Maximally tolerated dose of oblimersen sodium [ Time Frame: 8 days ]
- Potential antitumor activity (responses to therapy) [ Time Frame: Up to 3 years ]Will be analyzed using simple descriptive statistics only.
- Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level [ Time Frame: Day 6 and 8 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed extensive stage small cell lungcancer
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No active CNS disease
- CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 2 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- PT and PTT no greater than 1.5 times ULN
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergic reactions to compounds of similar chemical or biologic composition to study agents
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- See Disease Characteristics
- At least 1 week since prior CNS radiotherapy and recovered
- No prior radiotherapy to more than 25% of skeleton
- No other prior anticancer therapy
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent anticoagulation therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017251
United States, Illinois | |
University of Chicago Comprehensive Cancer Center | |
Chicago, Illinois, United States, 60637-1470 |
Principal Investigator: | Charles Rudin | University of Chicago Comprehensive Cancer Center |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00017251 History of Changes |
Other Study ID Numbers: |
NCI-2012-02387 10992A N01CM17102 ( U.S. NIH Grant/Contract ) CDR0000068667 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
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 phosphate Oblimersen Carboplatin Etoposide Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |