Extensive Stage Small Cell Lung CancerPhase 1NCT00017251
Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 1 study testing oblimersen sodium, carboplatin and etoposide in people with Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- oblimersen sodium, carboplatin and etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Jan 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 32Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
About this study
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
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- oblimersen sodium, carboplatin, etoposide, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oblimersen sodiumBiological
Also called augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Given IV
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
Given IV
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: oblimersen sodium; Drug: carboplatin; Drug: etoposide; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Maximally tolerated dose of oblimersen sodium
Measured: 8 days
Secondary outcomes (2)
Potential antitumor activity (responses to therapy)
Will be analyzed using simple descriptive statistics only.
Measured: 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.
Measured: Day 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2001
- Primary completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles Rudin, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017251
- Sponsor's protocol ID
- NCI-2012-02387
- Other IDs
- 10992A, N01CM17102, CDR0000068667
- Status last verified
- Jan 2013
- First submitted
- 6 Jun 2001
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00017251
- Acronym / sponsor ID
- NCI-2012-02387
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Jan 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (oblimersen sodium, carboplatin, etoposide) | Experimental | Biological: oblimersen sodium, Drug: carboplatin, Drug: etoposide, Other: pharmacological study, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Histologically or cytologically confirmed extensive stage small cell lungcancer
- No active CNS disease
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 2 months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oblimersen sodiumAlso: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, GenasenseGiven IV | Biological | Treatment (oblimersen sodium, carboplatin, etoposide) |
| carboplatinAlso: Carboplat, CBDCA, JM-8, ParaplatGiven IV | Drug | Treatment (oblimersen sodium, carboplatin, etoposide) |
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Treatment (oblimersen sodium, carboplatin, etoposide) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (oblimersen sodium, carboplatin, etoposide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (oblimersen sodium, carboplatin, etoposide) |
Primary outcome
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
2 secondary outcomes
Potential antitumor activity (responses to therapy)
Time frame: Up to 3 years
Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level
Time frame: Day 6 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Rudin principal investigator
University of Chicago Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oblimersen sodium, carboplatin and etoposide in people with Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0 (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.