Carcinoma, Squamous CellPhase 2NCT00432315
Docetaxel in Non Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Docetaxel + CDDP in people with Carcinoma, Squamous Cell, run by Sanofi at 1 site in Austria.
Trial summary
Primary objective: To assess the response rate to induction therapy with docetaxel/CDDP. Secondary objectives: To assess Resectability after induction therapy Time to progression Overall survival Safety profile Quality of Life Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- Docetaxel + CDDP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- May 2001to Oct 2009
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology and staging of the disease
- Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
- Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
- Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
- General conditions
- Karnofsky Status > 70, if age > 70 years → PS > 70
- Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 109/L, platelets > 100 x 109/L)
- Adequate renal and hepatic functions: total bilirubin < 1 x upper normal limit (UNL), serum creatinine < 1 x UNL, in case of limit value the creatinine clearance should be > 60 ml/min, ASAT and ALAT < 2.5 x UNL, alkaline phosphatase < 5 x UNL.
Who cannot join
- Diagnosis
- Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
- History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
- Other serious concomitant illness or medical condition:
- Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
- History of significant neurologic or psychiatric disorders, including dementia or seizure
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- Active infection requiring i.v. Antibiotics
- Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
- Hepatic function abnormality: ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL
- Current peripheral neuropathy WHO grade > 2
- Prior or concurrent therapy
- Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment
- Prior surgery or radiotherapy for NSCLC
- Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
- General conditions
- Pregnant or lactating patients
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
- 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 Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb
Primary objective:
- To assess the response rate to induction therapy with docetaxel/CDDP.
Secondary objectives:
To assess
- Resectability after induction therapy
- Time to progression
- Overall survival
- Safety profile
- Quality of Life
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- Docetaxel + CDDP
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + CDDPDrug
- 3 cycles chemotherapy : docetaxel + CDDP
- Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered)
- 3 cycles adjuvant chemotherapy docetaxel
docetaxel + CDDPDrug
- 3 cycles chemotherapy: docetaxel + CDDP
- Radiochemotherapy
- 3 cycles adjuvant chemotherapy docetaxel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Resectable NSCLC Receives: Drug: Docetaxel + CDDP |
| 2 | Experimental | Unresectable NSCSC Receives: Drug: docetaxel + CDDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response rate to induction therapy with docetaxel in combination with CDDP
Measured: every 3 months until tumour progression and thereafter every 6 months until death
Secondary outcomes (5)
Resectability after induction therapy
Measured: every 3 months until tumour progression and thereafter every 6 months until death
Time to progression
Measured: every 3 months until tumour progression and thereafter every 6 months until death
Overall survival
Measured: every 3 months until tumour progression and thereafter every 6 months until death
Safety profile
Measured: throughout the study
Quality of life
Measured: every 3 months until tumour progression and thereafter every 6 months until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startMay 2001
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandra Edlmayer, Dr., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432315
- Sponsor's protocol ID
- TAX_AT1_203
- Status last verified
- Sep 2010
- First submitted
- 6 Feb 2007
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb
- ClinicalTrials.gov ID
- NCT00432315
- Acronym / sponsor ID
- TAX_AT1_203
- Conditions
- Carcinoma, Squamous Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Feb 2007 (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.
Primary objective:
- To assess the response rate to induction therapy with docetaxel/CDDP.
Secondary objectives:
To assess
- Resectability after induction therapy
- Time to progression
- Overall survival
- Safety profile
- Quality of Life
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel + CDDPResectable NSCLC |
| 2 | Experimental | Drug: docetaxel + CDDPUnresectable NSCSC |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histology and staging of the disease
- General conditions
Key exclusion criteria (18 listed)
- Diagnosis
- Prior or concurrent therapy
- General conditions
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| Docetaxel + CDDP* 3 cycles chemotherapy : docetaxel + CDDP * Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) * 3 cycles adjuvant chemotherapy docetaxel | Drug | 1 |
| docetaxel + CDDP* 3 cycles chemotherapy: docetaxel + CDDP * Radiochemotherapy * 3 cycles adjuvant chemotherapy docetaxel | Drug | 2 |
Primary outcome
To assess the response rate to induction therapy with docetaxel in combination with CDDP
Time frame: every 3 months until tumour progression and thereafter every 6 months until death
5 secondary outcomes
Resectability after induction therapy
Time frame: every 3 months until tumour progression and thereafter every 6 months until death
Time to progression
Time frame: every 3 months until tumour progression and thereafter every 6 months until death
Overall survival
Time frame: every 3 months until tumour progression and thereafter every 6 months until death
Safety profile
Time frame: throughout the study
Quality of life
Time frame: every 3 months until tumour progression and thereafter every 6 months until death
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 14 Sep 2010.
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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.
Alexandra Edlmayer, Dr. 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 + CDDP in people with Carcinoma, Squamous Cell, run by Sanofi at 1 site in Austria.
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 18 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 14 Sep 2010. 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 Austria. 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.
What does the primary outcome measure?
To assess the response rate to induction therapy with docetaxel in combination with CDDP (time frame: every 3 months until tumour progression and thereafter every 6 months until death). 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 Sep 2010.