Erlotinib and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of One Chemotherapy Regimen

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00908336
• Other study ID #: ML25033
• Status: Recruiting
• Phase: Phase 2
• First received: May 21, 2009
• Last updated: May 22, 2009
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2009
• Source: Hospital Arnau de Vilanova
• Contact: Oscar Juan, Doctor
• Phone: 0034963868501
• Email: juan_osc[@]gva.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Docetaxel and Erlotinib
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
• Erlotinib
150 mg/day po daily

Locations

Country	Name	City	State
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	Hospital San Juan de Alicante	Alicante
Spain	Hospital Clínica de Benidorm	Benidorm	Alicante
Spain	Hospital Provincial de Castellón	Castellón de la Plana	Castellón
Spain	Hospital General de Elda	Elda	Alicante
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients without disease progression after 6 months of treatment.		6 months	No
Secondary	Progression-free survival		Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.	No
Secondary	Duration of Response		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.	No
Secondary	Overall Response Rate		The proportion of patients with tumor size reduction (complete response or partial response following RECIST criteria). Response will be assessed every 2 months.	No
Secondary	Disease Control Rate		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.	No
Secondary	Overall survival		Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.	No
Secondary	Safety profile		Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.	Yes