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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00908336 |
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Date of registration:
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21/05/2009 |
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Primary sponsor: |
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Public title:
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Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
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Scientific title:
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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 |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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70 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00908336 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Oscar Juan, Doctor |
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Address:
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Telephone:
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0034963868501 |
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Email:
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juan_osc@gva.es |
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Affiliation:
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Name:
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José Muñoz, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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H. Universitario Dr. Peset |
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Name:
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Oscar Juan, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Arnau de Vilanova de Valencia |
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Name:
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Gaspar Esquerdo, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Clínica de Benidorm |
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Name:
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Vicente Giner, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Sagunto |
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Name:
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Sonia Maciá, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital General de Elda |
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Name:
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Alfredo Sánchez, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Provincial de Castellón |
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Name:
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Antonio López, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital San Juan de Alicante |
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Name:
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Francisco Aparisi, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Virgen de los Lirios |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: Docetaxel and Erlotinib
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Drug: Erlotinib
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Primary Outcome(s)
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Percentage of patients without disease progression after 6 months of treatment.
[Time Frame: 6 months]
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Secondary Outcome(s)
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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.]
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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.]
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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.]
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Overall survival
[Time Frame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.]
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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.]
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Safety profile
[Time Frame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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