Carcinoma, Non-Small-Cell LungPhase 2NCT00819728
Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Docetaxel and Irinotecan in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi at 1 site in United States.
Trial summary
The main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell 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?
- Docetaxel and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Jan 2003
- 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
- Microscopically or cytologically confirmed non-small cell lung cancer. Histology may include large cell, squamous cell, undifferentiated, or bronchioalveolar carcinoma, or adenocarcinoma, but no small cell or carcinoid.
- Inoperable stage III B or metastatic stage IV NSCLC
- Measurable (bidimensionally) indicator lesion(s) which have not been irradiated.
- No prior systemic chemotherapy. Prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal or there must be radiologic proof of progressive disease. If a patient is receiving palliative radiation, other than the chest, to one site at 30 cGy or less, then the patient is eligible and chemotherapy can proceed immediately after palliative RT.
- ECOG performance status 0 or 1 at screening and on the first day of treatment
- Life expectancy = 12 weeks.
- Patients must be > 4 weeks from prior radiation therapy to the pelvis, spine or long bones, and must be recovered from all side effects.
- Patients must be > 3 weeks from prior major surgery, except for a simple biopsy or placement of a venous access device.
Who cannot join
- No patient may have the following:
- Neutrophils < 1,500/mm3.
- Platelets < 100,000/mm3.
- Serum creatinine >1.8 mg/dL.
- SGOT > 1.5 times the upper limit of normal for institution.
- Total bilirubin > the upper limit of normal for institution.
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- Alkaline phosphatase > 5 times the upper limit of normal for institution.
- Pregnant or lactating females or females of childbearing potential not employing adequate contraception.
- History of other malignancy within the last five years which could affect the diagnosis of NSCLC, except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Current metastatic CNS disease, if present, must have been treated and clinically stable for at least 3 weeks prior to initial Taxotere treatment. Patients with documented meningeal carcinomatosis are not eligible.
- Grade 2 or greater peripheral neuropathy.
- Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
- Patients who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and patients whose circumstances do not permit completion of the study or the required follow-up.
- Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
- Patients requiring concurrent treatment with corticosteroids unless chronic treatment (> 6 months) at low doses (< 20 mg/day of methylprednisolone or equivalent).
- Patients receiving an investigational drug within 3 weeks of registration.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
The main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell lung cancer. It is also to determine the activity of this combination in terms of response duration, time to progression, median survival, overall survival, and percent one-year survival, as well as the side-effect and toxicity profile of weekly Taxotere and weekly irinotecan.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Docetaxel, Irinotecan
- 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.
DocetaxelDrug
Also called Taxotere
35mg/m2 IV each week for 4 weeks
IrinotecanDrug
50mg/m2 IV each week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Taxotere/Irinotecan | Experimental | Not described Receives: Drug: Docetaxel; Drug: Irinotecan |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJun 2000
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yasir Nagarwala, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819728
- Sponsor's protocol ID
- RP56976_US1_203
- Status last verified
- Jan 2011
- First submitted
- 7 Jan 2009
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00819728
- Acronym / sponsor ID
- RP56976_US1_203
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Study completion
- Jan 2003 (actual)
- First posted
- 9 Jan 2009 (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 main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell lung cancer. It is also to determine the activity of this combination in terms of response duration, time to progression, median survival, overall survival, and percent one-year survival, as well as the side-effect and toxicity profile of weekly Taxotere and weekly irinotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxotere/Irinotecan | Experimental | Drug: Docetaxel, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Microscopically or cytologically confirmed non-small cell lung cancer. Histology may include large cell, squamous cell, undifferentiated, or bronchioalveolar carcinoma, or adenocarcinoma, but no small cell or carcinoid.
- Inoperable stage III B or metastatic stage IV NSCLC
- Measurable (bidimensionally) indicator lesion(s) which have not been irradiated.
- No prior systemic chemotherapy. Prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal or there must be radiologic proof of progressive disease. If a patient is receiving palliative radiation, other than the chest, to one site at 30 cGy or less, then the patient is eligible and chemotherapy can proceed immediately after palliative RT.
- ECOG performance status 0 or 1 at screening and on the first day of treatment
Key exclusion criteria (17 listed)
- No patient may have the following:
- Neutrophils < 1,500/mm3.
- Platelets < 100,000/mm3.
- Serum creatinine >1.8 mg/dL.
- SGOT > 1.5 times the upper limit of normal for institution.
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 |
|---|---|---|
| DocetaxelAlso: Taxotere35mg/m2 IV each week for 4 weeks | Drug | Taxotere/Irinotecan |
| Irinotecan50mg/m2 IV each week for 4 weeks | Drug | Taxotere/Irinotecan |
Primary outcome
Not reported in the source record.
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 11 Jan 2011.
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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.
Yasir Nagarwala, MD study director
Sanofi
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 Docetaxel and Irinotecan in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi 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 8 inclusion and 17 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 11 Jan 2011. 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 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.
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 11 Jan 2011.