search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Docetaxel and Erlotinib
Erlotinib
Sponsored by
Hospital Arnau de Vilanova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Virgen de los LiriosRecruiting
  • Hospital Clínica de BenidormRecruiting
  • Hospital General de Elda
  • Hospital Provincial de CastellónRecruiting
  • Hospital de SaguntoRecruiting
  • Hospital San Juan de AlicanteRecruiting
  • Hospital Arnau de VilanovaRecruiting
  • Hospital Universitario Dr. PesetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Docetaxel and Erlotinib

Erlotinib

Arm Description

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.

Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-free survival
Duration of Response
Overall Response Rate
Disease Control Rate
Overall survival
Safety profile

Full Information

First Posted
May 21, 2009
Last Updated
May 22, 2009
Sponsor
Hospital Arnau de Vilanova
search

1. Study Identification

Unique Protocol Identification Number
NCT00908336
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Arnau de Vilanova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Adenocarcinoma, Carcinoma, Non-Small Cell, Lung Neoplasms, Docetaxel, Erlotinib, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel and Erlotinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Erlotinib
Arm Type
Active Comparator
Arm Description
Erlotinib (Tarceva®) 150 mg/day po daily until disease progression, unacceptable toxicity, patient refusal or investigator's decision to discontinue the treatment.
Intervention Type
Drug
Intervention Name(s)
Docetaxel and Erlotinib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
150 mg/day po daily
Primary Outcome Measure Information:
Title
Percentage of patients without disease progression after 6 months of treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
Overall survival
Time Frame
Time from randomization until death from any cause. Follow up wil be assessed every 3 months after finishing study treatment.
Title
Safety profile
Time Frame
Toxicity will be discribed per cycle and per patient according to CTCAE vs. 3, every 3 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Juan, Doctor
Phone
0034963868501
Email
juan_osc@gva.es
First Name & Middle Initial & Last Name or Official Title & Degree
Vicente Alberola, Doctor
Phone
0034649974055
Email
alberola_vicara@gva.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Juan, Doctor
Organizational Affiliation
Hospital Arnau de Vilanova de Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaspar Esquerdo, Doctor
Organizational Affiliation
Hospital Clínica de Benidorm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfredo Sánchez, Doctor
Organizational Affiliation
Hospital Provincial de Castellón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonia Maciá, Doctor
Organizational Affiliation
Hospital General de Elda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vicente Giner, Doctor
Organizational Affiliation
Hospital de Sagunto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Muñoz, Doctor
Organizational Affiliation
H. Universitario Dr. Peset
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio López, Doctor
Organizational Affiliation
Hospital San Juan de Alicante
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Aparisi, Doctor
Organizational Affiliation
Hospital Virgen de los Lirios
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen de los Lirios
City
Alcoy
State/Province
Alicante
ZIP/Postal Code
3804
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Aparisi, Doctor
Phone
0034966528804
Email
joseponcelorenzo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Francisco Aparisi, Doctor
Facility Name
Hospital Clínica de Benidorm
City
Benidorm
State/Province
Alicante
ZIP/Postal Code
03501
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaspar Esquerdo, Doctor
Phone
0034965853850
Email
gesquerdo@clinicabenidorm.com
First Name & Middle Initial & Last Name & Degree
Gaspar Esquerdo, Doctor
Facility Name
Hospital General de Elda
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Maciá, Doctor
Phone
0034966989109
Email
smacia@tiscali.es
First Name & Middle Initial & Last Name & Degree
Sonia Maciá, Doctor
Facility Name
Hospital Provincial de Castellón
City
Castellón de la Plana
State/Province
Castellón
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfreso Sánchez, Doctor
Phone
0034964354350
Email
asanchezh@seom.org
First Name & Middle Initial & Last Name & Degree
Alfredo Sánchez, Doctor
Facility Name
Hospital de Sagunto
City
Sagunto
State/Province
Valencia
ZIP/Postal Code
46520
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Giner, Doctor
Phone
0034962659405
Email
vginermaco@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vicente Giner, Doctor
Facility Name
Hospital San Juan de Alicante
City
Alicante
ZIP/Postal Code
03550
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio López, Doctor
Phone
0034965938639
Email
aljimenez73@hotmail.com
First Name & Middle Initial & Last Name & Degree
Antonio López, Doctor
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Juan, Doctor
Phone
0034963868500
Email
juan_osc@gva.es
First Name & Middle Initial & Last Name & Degree
Oscar Juan, Doctor
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Muñoz, Doctor
Phone
0034961262300
Email
munyoz_joslan@gva.es
First Name & Middle Initial & Last Name & Degree
José Muñoz, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs