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Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
carboplatin
etoposide
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed extensive stage small cell lungcancer 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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oblimersen sodium, carboplatin, etoposide)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Maximally tolerated dose of oblimersen sodium

Secondary Outcome Measures

Potential antitumor activity (responses to therapy)
Will be analyzed using simple descriptive statistics only.
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.

Full Information

First Posted
June 6, 2001
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017251
Brief Title
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oblimersen sodium, carboplatin, etoposide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Other Intervention Name(s)
augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
EPEG, VP-16, VP-16-213
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
Description
Data will be summarized separately for each dose level, by severity, and type of toxicity.
Time Frame
Up to 3 years
Title
Maximally tolerated dose of oblimersen sodium
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Potential antitumor activity (responses to therapy)
Description
Will be analyzed using simple descriptive statistics only.
Time Frame
Up to 3 years
Title
Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extensive stage small cell lungcancer 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Rudin
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

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