Non-Small Cell Lung CancerPhase 2NCT00908336
Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
A Phase 2 study testing Docetaxel and Erlotinib and Erlotinib in people with Non-Small Cell Lung Cancer, run by Hospital Arnau de Vilanova at 8 sites in Spain.
Trial summary
Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Docetaxel and Erlotinib and Erlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesSpain
- Study dates
- Mar 2009to Dec 2010
- 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
- Written informed consent.
- Age >= 18 years.
- Histologically or cytologically documented inoperable, locally advanced (stage IIIb with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.
- Patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment.
- ECOG PS 0-2.
- Adequate hematological function: hemoglobin => 9 g/dl; neutrophils count => 1.5 x 10(9)/l; platelet count => 100 x 10(9)/l.
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- Adequate liver function: Bilirubin <= 1,5 x ULN; AST and ALT <= x 3 ULN when no hepatic metastases or <=5 x ULN if hepatic metastases; Alkaline phosphatase <=5 x UNL except that there is hepatic metastases.
- Adequate renal function: Calculated creatinine clearance => 40 mL/min (Cockroft y Gault) or serum creatinine <= 1.5 x ULN .
- Patient able to meet the requirements of the study and accessible for correct follow-up.
- Oral swallowing capability.
Who cannot join
- Previous treated with more than one chemotherapeutic treatment for NSCLC
- Concomitant treatment with another drug under investigation.
- Pregnancy or lactation. Fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. In addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study.
- Evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- Contraindication for the use of erlotinib or docetaxel.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Hospital Virgen de los Lirios
Alcoy, Alicante, 3804
Francisco Aparisi, Doctor, 0034966528804, joseponcelorenzo@hotmail.com
Francisco Aparisi, Doctor
- Recruiting
Hospital San Juan de Alicante
Alicante, Alicante, 03550
Antonio López, Doctor, 0034965938639, aljimenez73@hotmail.com
Antonio López, Doctor
- Recruiting
Hospital Clínica de Benidorm
Benidorm, Alicante, 03501
Gaspar Esquerdo, Doctor, 0034965853850, gesquerdo@clinicabenidorm.com
Gaspar Esquerdo, Doctor
- Recruiting
Hospital Provincial de Castellón
Castellon, Castellón, 12002
Alfreso Sánchez, Doctor, 0034964354350, asanchezh@seom.org
Alfredo Sánchez, Doctor
- Not yet recruiting
Hospital General de Elda
Elda, Alicante, 03600
Sonia Maciá, Doctor, 0034966989109, smacia@tiscali.es
Sonia Maciá, Doctor
- Recruiting
Hospital de Sagunto
Sagunto, Valencia, 46520
Vicente Giner, Doctor, 0034962659405, vginermaco@hotmail.com
Vicente Giner, Doctor
- Recruiting
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
Oscar Juan, Doctor, 0034963868500, juan_osc@gva.es
Oscar Juan, Doctor
- Recruiting
Hospital Universitario Dr. Peset
Valencia, Valencia, 46017
José Muñoz, Doctor, 0034961262300, munyoz_joslan@gva.es
José Muñoz, Doctor
About this study
Official title: Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen
Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population.
However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy.
This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Docetaxel and Erlotinib, Erlotinib
- Keywords
- Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and ErlotinibDrug
Docetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression
ErlotinibDrug
150 mg/day po daily
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Erlotinib | Experimental | Patients in the experimental arm will receive sequential treatment of intermittent erlotinib and docetaxel up to 4 cycles in the absence of disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
After 4 cycles, participants will receive 150 mg of erlotinib per day until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. Receives: Drug: Docetaxel and Erlotinib |
| Erlotinib | Active comparator | Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without disease progression after 6 months of treatment.
Measured: 6 months
Secondary outcomes (6)
Progression-free survival
Measured: Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.
Duration of Response
Measured: The time from the first complete response or partial response until objective tumor progression or death due to progression disease. Tumour progression will be assessed every 2 months.
Overall Response Rate
Measured: The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.
Disease Control Rate
Measured: The proportion of patients without tumor size increase (complete response, partial response or stable disease following RECIST criteria). Response wil be assessed every 2 months.
Overall survival
Measured: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.
Safety profile
Measured: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Investigators
- Oscar Juan, Doctor, Principal investigator, Hospital Arnau de Vilanova de ValenciaGaspar Esquerdo, Doctor, Principal investigator, Hospital Clínica de BenidormAlfredo Sánchez, Doctor, Principal investigator, Hospital Provincial de CastellónSonia Maciá, Doctor, Principal investigator, Hospital General de EldaVicente Giner, Doctor, Principal investigator, Hospital de SaguntoJosé Muñoz, Doctor, Principal investigator, H. Universitario Dr. PesetAntonio López, Doctor, Principal investigator, Hospital San Juan de AlicanteFrancisco Aparisi, Doctor, Principal investigator, Hospital Virgen de los Lirios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908336
- Sponsor's protocol ID
- ML25033
- Status last verified
- May 2009
- First submitted
- 21 May 2009
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicenter, Randomized, Open Label Study of a Sequential Treatment of Intermittent Erlotinib and Docetaxel Versus Erlotinib in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer After Failure of a Prior Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00908336
- Acronym / sponsor ID
- ML25033
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 May 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.
Erlotinib has demonstrated efficacy as a single agent in patients with NSCLC and the addition of erlotinib to chemotherapy has not achieved better results in the general population.
However, several preclinical and phase I studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy.
This study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Erlotinib | Experimental | Drug: Docetaxel and ErlotinibPatients in the experimental arm will receive sequential treatment of intermittent erlotinib and docetaxel up to 4 cycles in the absence of disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. After 4 cycles, participants will receive 150 mg of erlotinib per day until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. |
| Erlotinib | Active comparator | Drug: ErlotinibErlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent.
- Age >= 18 years.
- Histologically or cytologically documented inoperable, locally advanced (stage IIIb with malignant pleural or pericardial effusion) or metastatic (Stage IV) NSCLC.
- Patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment.
- ECOG PS 0-2.
Key exclusion criteria (5 listed)
- Previous treated with more than one chemotherapeutic treatment for NSCLC
- Concomitant treatment with another drug under investigation.
- Pregnancy or lactation. Fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. In addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study.
- Evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.
- Contraindication for the use of erlotinib or docetaxel.
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 and ErlotinibDocetaxel (Taxotere®) 75 mg/m2 iv first day of each 21-day cycle. Erlotinib (Tarceva®) 150 mg po days 2-16 of each 21-day cycle. Total: 4 cycles in the absence of disease progression | Drug | Docetaxel and Erlotinib |
| Erlotinib150 mg/day po daily | Drug | Erlotinib |
Primary outcome
Percentage of patients without disease progression after 6 months of treatment.
Time frame: 6 months
6 secondary outcomes
Progression-free survival
Time frame: Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.
Duration of Response
Time frame: The time from the first complete response or partial response until objective tumor progression or death due to progression disease. Tumour progression will be assessed every 2 months.
Overall Response Rate
Time frame: The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.
Disease Control Rate
Time frame: The proportion of patients without tumor size increase (complete response, partial response or stable disease following RECIST criteria). Response wil be assessed every 2 months.
Overall survival
Time frame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.
Safety profile
Time frame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2009.
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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.
Oscar Juan, Doctor principal investigator
Hospital Arnau de Vilanova de Valencia
Gaspar Esquerdo, Doctor principal investigator
Hospital Clínica de Benidorm
Alfredo Sánchez, Doctor principal investigator
Hospital Provincial de Castellón
8 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 Docetaxel and Erlotinib and Erlotinib in people with Non-Small Cell Lung Cancer, run by Hospital Arnau de Vilanova at 8 sites in Spain.
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 10 inclusion and 5 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 25 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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 Oscar Juan, Doctor (0034963868501, juan_osc@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients without disease progression after 6 months of treatment. (time frame: 6 months). 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 25 May 2009.