Previously Treated Metastatic Non-Small Cell Lung CancerPhase 2NCT00238849
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
A Phase 2 study testing Oxaliplatin in people with Previously Treated Metastatic Non-Small Cell Lung Cancer, run by Integrated Community Oncology Network at 2 sites in United States.
Trial summary
The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Previously Treated Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Oxaliplatin
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
- Measurable disease
- Good performance status (ECOG 0,1 or 2)
Who cannot join
- Previously treated with Oxaliplatin or Navelbine
- Symptomatic CNS metastases
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Diane Edwards, RN,OCN,CCRP, 904-363-7471, diane.edwards@foa.cc
Gloria Perez, RN,BSN,OCN, 904-739-7779, gloria.perez@foa.cc
Integrated Community Oncology Network
Orange Park, Florida, 32073
Carla Malott, RN, 904-272-3139, carla.malott@foa.cc
Joan Ollie, BSN, RN, 904-272-3139, joan.ollie@foa.cc
About this study
Official title: Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.
Read the detailed description
This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.
- Being tested
- Oxaliplatin
- Keywords
- Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (4)
Time to progression
Duration of response
Survival
Toxicity profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previously Treated Metastatic Non-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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Integrated Community Oncology Network
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Thomas A Marsland, MD, Principal investigator, Integrated Community Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238849
- Sponsor's protocol ID
- OX-03-087
- Other IDs
- ELVIS II
- Status last verified
- Oct 2005
- First submitted
- 12 Oct 2005
- Last updated
- 14 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00238849
- Acronym / sponsor ID
- OX-03-087
- Keywords
- Non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Integrated Community Oncology NetworkUniversity, hospital or other
- Collaborators
- Sanofi
- First posted
- 14 Oct 2005 (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 response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.
Detailed description
This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.
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)
- Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
- Measurable disease
- Good performance status (ECOG 0,1 or 2)
Key exclusion criteria (2 listed)
- Previously treated with Oxaliplatin or Navelbine
- Symptomatic CNS metastases
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 |
|---|---|---|
| Oxaliplatin | Drug | – |
Primary outcome
Efficacy
4 secondary outcomes
Time to progression
Duration of response
Survival
Toxicity profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2005.
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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.
Thomas A Marsland, MD principal investigator
Integrated Community Oncology Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin in people with Previously Treated Metastatic Non-Small Cell Lung Cancer, run by Integrated Community Oncology Network at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane L Edwards, RN,OCN, CCRP (904-363-7471, diane.edwards@foa.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. 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 14 Oct 2005.