Clinical trial NCT00908336: Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Adenocarcinoma
Carcinoma, Non-Small Cell
Lung Neoplasms
Docetaxel
Erlotinib
Chemotherapy
Lead sponsor: Hospital Arnau de Vilanova
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients without disease progression after 6 months of treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.
measure: Duration of Response
timeFrame: 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.
measure: Overall Response Rate
timeFrame: The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.
measure: Disease Control Rate
timeFrame: 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.
measure: Overall survival
timeFrame: Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.
measure: Safety profile
timeFrame: Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Benidorm
country: Spain
facility: Hospital Clínica de Benidorm
state: Alicante
city: Elda
country: Spain
facility: Hospital General de Elda
state: Alicante
city: Castellón de la Plana
country: Spain
facility: Hospital Provincial de Castellón
state: Castellón
city: Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Alicante
country: Spain
facility: Hospital San Juan de Alicante
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
affiliation: Hospital Arnau de Vilanova de Valencia
name: Oscar Juan, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínica de Benidorm
name: Gaspar Esquerdo, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Provincial de Castellón
name: Alfredo Sánchez, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de Elda
name: Sonia Maciá, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sagunto
name: Vicente Giner, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Universitario Dr. Peset
name: José Muñoz, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Juan de Alicante
name: Antonio López, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de los Lirios
name: Francisco Aparisi, Doctor
role: PRINCIPAL_INVESTIGATOR
References: