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

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.

Study Overview

• Status: Unknown
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel and Erlotinib; Drug: Erlotinib

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03550
    • Recruiting
    • Hospital San Juan de Alicante
  • Valencia, Spain, 46017
    • Recruiting
    • Hospital Universitario Dr. Peset
  • Valencia, Spain, 46015
    • Recruiting
    • Hospital Arnau de Vilanova
  • Alicante
    • Alcoy, Alicante, Spain, 3804
      • Recruiting
      • Hospital Virgen de los Lirios
    • Benidorm, Alicante, Spain, 03501
      • Recruiting
      • Hospital Clínica de Benidorm
    • Elda, Alicante, Spain, 03600
      • Not yet recruiting
      • Hospital General de Elda
  • Castellón
    • Castellón de la Plana, Castellón, Spain, 12002
      • Recruiting
      • Hospital Provincial de Castellon
  • Valencia
    • Sagunto, Valencia, Spain, 46520
      • Recruiting
      • Hospital de Sagunto
      • Contact: Vicente Giner, Doctor; Phone Number: 0034962659405; Email: vginermaco@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel and Erlotinib; 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; 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
Active Comparator: Erlotinib; Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.	Drug: Erlotinib; 150 mg/day po daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients without disease progression after 6 months of treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
Safety profile	Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.

Collaborators and Investigators

• Sponsor: Hospital Arnau de Vilanova
• Investigators: Principal Investigator: Oscar Juan, Doctor, Hospital Arnau de Vilanova de Valencia

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimate): May 25, 2009

Study Record Updates

• Last Update Posted (Estimate): May 25, 2009
• Last Update Submitted That Met QC Criteria: May 22, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Docetaxel; Adenocarcinoma; Erlotinib; Chemotherapy; Lung Neoplasms; Carcinoma, Non-Small Cell
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protein Kinase Inhibitors; Docetaxel; Erlotinib Hydrochloride
• Other Study ID Numbers: ML25033