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

NCT00908336 | Unknown Phase 2

• 1 other identifier: ML25033
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Adenocarcinoma; Carcinoma, Non-Small Cell; Lung Neoplasms; Docetaxel; Erlotinib; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients without disease progression after 6 months of treatment.

  6 months

Secondary Outcomes (6)

• Progression-free survival

  Time from randomization until objective tumor progression or death for any cause. Tumour progression will be assessed every 2 months.

• 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.

• 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.

• 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.

• Overall survival

  Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.

Study Arms (2)

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.

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.

Drug: Erlotinib

Interventions

Docetaxel and Erlotinib DRUG

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

Docetaxel and Erlotinib

Erlotinib DRUG

150 mg/day po daily

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead

Study Sites (8)

Hospital Virgen de los Lirios

Alcoy, Alicante, 3804, Spain

RECRUITING

Hospital San Juan de Alicante

Alicante, Alicante, 03550, Spain

RECRUITING

Hospital Clínica de Benidorm

Benidorm, Alicante, 03501, Spain

RECRUITING

Hospital General de Elda

Elda, Alicante, 03600, Spain

NOT YET RECRUITING

Hospital Provincial de Castellón

Castellon, Castellón, 12002, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

RECRUITING

Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma; Lung Neoplasms

Interventions

Docetaxel; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oscar Juan, Doctor

  Hospital Arnau de Vilanova de Valencia

  PRINCIPAL INVESTIGATOR

• Gaspar Esquerdo, Doctor

  Hospital Clínica de Benidorm

  PRINCIPAL INVESTIGATOR

• Alfredo Sánchez, Doctor

  Hospital Provincial de Castellón

  PRINCIPAL INVESTIGATOR

• Sonia Maciá, Doctor

  Hospital General de Elda

  PRINCIPAL INVESTIGATOR

• Vicente Giner, Doctor

  Hospital de Sagunto

  PRINCIPAL INVESTIGATOR

• José Muñoz, Doctor

  H. Universitario Dr. Peset

  PRINCIPAL INVESTIGATOR

• Antonio López, Doctor

  Hospital San Juan de Alicante

  PRINCIPAL INVESTIGATOR

• Francisco Aparisi, Doctor

  Hospital Virgen de los Lirios

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Juan, Doctor

CONTACT

0034963868501; juan_osc@gva.es

Vicente Alberola, Doctor

CONTACT

0034649974055; alberola_vicara@gva.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 25, 2009

Record last verified: 2009-05

Locations

ES (8)