Carcinoma, Non-Small-Cell LungPhase 2NCT00145418
Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Oxaliplatin + Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Oncology Specialists, S.C. at 1 site in United States.
Trial summary
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Oxaliplatin + Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 non-small-cell lung cancer (NSCLC)
- Patients must have measurable disease
- Age greater than or equal to 18 years
- ECOG performance score of 0, 1, or 2
- Absolute neutrophil count (ANC) > 1,500
- Platelets > 100,000
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- Serum creatinine < 1.5mg/dL
- Serum total bilirubin < 1.5mg/dL
- Alkaline phosphatase < 3 times the upper limit of normal
- SGOT/SGPT < 3 times the upper limit of normal
- Patients must be recovered from the effects of any prior surgery or RT.
- Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
- Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.
Who cannot join
- Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
- Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
- Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
- Patients who have had prior chemotherapy for lung cancer
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
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- Grade 2 peripheral neuropathy
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
- History of allogeneic transplant
- Known HIV, hepatitis B or C (active, previously treated, or both)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oncology Specialists, SC
Park Ridge, Illinois, 60068
About this study
Official title: Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.
Read the detailed description
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:
- oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
- docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Oxaliplatin + Docetaxel
- Keywords
- Non small Cell Lung Cancer Stage IIIb and IV
- 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.
Oxaliplatin + DocetaxelDrug
Also called Eloxatin
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Receives: Drug: Oxaliplatin + Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.
Measured: Response is measured every 2 cycles until disease progression
Secondary outcomes (3)
Time to Progression
Progression is measured from each participants start of study until removal from treatment.
Measured: <1 cycle to 6 cycles of treatment
Duration of Response
Duration of response is a measure of how long the participants response to therapy was maintained.
Measured: 0 -12 months
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.
Measured: day one of cycle one until participant removed from trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionAug 2009
- Study completionMar 2010
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncology Specialists, S.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Responsible party
- Principal investigator, Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
- Investigators
- Chadi Nabhan, MD, Principal investigator, Oncology Specialists, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145418
- Sponsor's protocol ID
- OX-03-137 (0409)
- Status last verified
- Jun 2014
- First submitted
- 1 Sep 2005
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating the Safety and Efficacy of Eloxatin (Oxaliplatin) and Docetaxel as First-line Therapy of Stage IV or IIIB Unresectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00145418
- Acronym / sponsor ID
- OX-03-137 (0409)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non small Cell Lung Cancer Stage IIIb and IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oncology Specialists, S.C.University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Feb 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.
Detailed description
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:
- oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
- docetaxel 30mg/m2 on Days 1 and 8
Cycles are to be repeated every 28 days for a maximum of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxaliplatin + DocetaxelOxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC)
- Patients must have measurable disease
- Age greater than or equal to 18 years
- ECOG performance score of 0, 1, or 2
- Absolute neutrophil count (ANC) > 1,500
Key exclusion criteria (11 listed)
- Patients with an active infection > 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment
- Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial.
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of < 1.0 mg/dL
- Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel
- Patients who have had prior chemotherapy for lung cancer
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 + DocetaxelAlso: EloxatinOxaliplatin 85mg/m2 Docetaxel 30mg.m2 | Drug | 1 |
Primary outcome
Response Rate
Time frame: Response is measured every 2 cycles until disease progression
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.
3 secondary outcomes
Time to Progression
Time frame: <1 cycle to 6 cycles of treatment
Duration of Response
Time frame: 0 -12 months
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.
Time frame: day one of cycle one until participant removed from trial
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chadi Nabhan, MD principal investigator
Oncology Specialists, SC
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 Oxaliplatin + Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Oncology Specialists, S.C. 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 13 inclusion and 11 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 30 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (time frame: Response is measured every 2 cycles until disease progression). 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 30 Jun 2014.