NCT00017251|CompletedPhase 1

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

A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2012-0238710992AN01CM17102CDR0000068667

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedApr 2001

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed

1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed

Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

June 6, 2001

Last Update Submit

January 23, 2013

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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.
Up to 3 years
Maximally tolerated dose of oblimersen sodium
8 days

Secondary Outcomes (2)

Potential antitumor activity (responses to therapy)
Up to 3 years
Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level
Day 6 and 8

Study Arms (1)

Treatment (oblimersen sodium, carboplatin, etoposide)

EXPERIMENTAL

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 sodiumDrug: carboplatinDrug: etoposideOther: pharmacological studyOther: laboratory biomarker analysis