Small Cell Lung CancerPhase 2NCT00316433
Oxaliplatin/CPT-11 for Extensive Stage Small Cell Lung Cancer
A Phase 2 study testing Irinotecan (CPT-11) and Oxaliplatin (Eloxatin) in people with Small Cell Lung Cancer, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Irinotecan (CPT-11) and Oxaliplatin (Eloxatin)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2007
- Phase
- Phase 2
- 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
- Previously untreated extensive small cell lung cancer
- No prior chemotherapy
- No prior radiotherapy except for the treatment of brain metastases
Who cannot join
- Prior treatment for extensive stage small cell lung cancer
- Known hypersensitivity to any of the components of oxaliplatin or CPT-11
- Greater than grade 2 peripheral neuropathy
- Known HIV or Hepatitis B or C (active, previously treated or both)
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer
The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Irinotecan (CPT-11), Oxaliplatin (Eloxatin)
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan (CPT-11)Drug
Oxaliplatin (Eloxatin)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startFeb 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Investigators
- Howard (Jack) West, MD, Principal investigator, Swedish Medical Center Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316433
- Sponsor's protocol ID
- OX-03-099
- Status last verified
- Apr 2007
- First submitted
- 18 Apr 2006
- Last updated
- 5 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin and CPT-11 as First Line Treatment for Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00316433
- Acronym / sponsor ID
- OX-03-099
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Feb 2005
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Apr 2006 (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.
The purpose of this study is to determine the safety and effectiveness of the combination of oxaliplatin and irinotecan (CPT-11) in patients with previously untreated, advanced small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously untreated extensive small cell lung cancer
- No prior chemotherapy
- No prior radiotherapy except for the treatment of brain metastases
Key exclusion criteria (4 listed)
- Prior treatment for extensive stage small cell lung cancer
- Known hypersensitivity to any of the components of oxaliplatin or CPT-11
- Greater than grade 2 peripheral neuropathy
- Known HIV or Hepatitis B or C (active, previously treated or both)
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 |
|---|---|---|
| Irinotecan (CPT-11) | Drug | – |
| Oxaliplatin (Eloxatin) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
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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.
Howard (Jack) West, MD principal investigator
Swedish Medical Center Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan (CPT-11) and Oxaliplatin (Eloxatin) in people with Small Cell Lung Cancer, run by Swedish Medical Center 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Apr 2007. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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.
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 5 Apr 2007.