Back to resultsBiweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Gemcitabine and Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Small Cell, Lung Neoplasms, Docetaxel, Gemcitabine, ECOG 2
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced NSCLC.
- Stage III with pleural effusion and stage IV.
- Patients with ECOG PS 2.
- Patients must have at least one measurable lesion, no previously irradiated.
- Life expectancy of at least 12 weeks.
Adequate organ function according to the following criteria:
- Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L; Hemoglobin => 10 g/dL.
- Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and ALT <= 1.5 x ULN.
- Renal function:serum creatinine <= 2mg/dL.
Exclusion Criteria:
- Prior systemic chemotherapy for advanced disease.
- Prior radiotherapy for NSCLC.
- Patients with symptomatic brain metastases.
- No measurable bone metastases or malignant pleural effusion as only measurable lesion.
- History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
- History of hypersensitivity reaction study drugs.
- Pregnant or lactating women (women of childbearing potential must use adequate contraception).
- Concurrent treatment with other experimental drugs.
- Current peripheral neuropathy NCI grade 2.
- Participation in clinical trials within 30 days of study entry.
- Major surgery, open biopsy or traumatic lesion 28 days before to study start.
Sites / Locations
- Hospital Virgen de los LiriosRecruiting
- Hospital Clínica de BenidormRecruiting
- Hospital General de EldaRecruiting
- Hospital Althaia, Xarxa Asistencial de ManresaRecruiting
- Hospital Provincial de CastellónRecruiting
- Hospital de SaguntoRecruiting
- Hospital Universitario de AlicanteRecruiting
- Hospital San Juan de AlicanteRecruiting
- Hospital Universitario La FeRecruiting
- Instituto Valenciano de OncologíaRecruiting
- Hospital Arnau de VilanovaRecruiting
- Hospital Universitario Dr. PesetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine and Docetaxel
Arm Description
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Outcomes
Primary Outcome Measures
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Secondary Outcome Measures
Overall survival
Toxicity
Duration of response
Time to progression
Measurement of quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00906061
Brief Title
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Official Title
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Arnau de Vilanova
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
Carcinoma, Small Cell, Lung Neoplasms, Docetaxel, Gemcitabine, ECOG 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine and Docetaxel
Arm Type
Experimental
Arm Description
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine and Docetaxel
Intervention Description
Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6
Primary Outcome Measure Information:
Title
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time Frame
2 and 4 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Time from study entry to death from any cause
Title
Toxicity
Time Frame
Biweekly
Title
Duration of response
Time Frame
time from first response (CR or PR) to tumor progression
Title
Time to progression
Time Frame
time from study entry to observed tumor progression or death due to progression disease
Title
Measurement of quality of life
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of advanced NSCLC.
Stage III with pleural effusion and stage IV.
Patients with ECOG PS 2.
Patients must have at least one measurable lesion, no previously irradiated.
Life expectancy of at least 12 weeks.
Adequate organ function according to the following criteria:
Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L; Hemoglobin => 10 g/dL.
Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and ALT <= 1.5 x ULN.
Renal function:serum creatinine <= 2mg/dL.
Exclusion Criteria:
Prior systemic chemotherapy for advanced disease.
Prior radiotherapy for NSCLC.
Patients with symptomatic brain metastases.
No measurable bone metastases or malignant pleural effusion as only measurable lesion.
History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
History of hypersensitivity reaction study drugs.
Pregnant or lactating women (women of childbearing potential must use adequate contraception).
Concurrent treatment with other experimental drugs.
Current peripheral neuropathy NCI grade 2.
Participation in clinical trials within 30 days of study entry.
Major surgery, open biopsy or traumatic lesion 28 days before to study start.
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
Study Director
First Name & Middle Initial & Last Name & Degree
Alfredo Sanchez, Doctor
Organizational Affiliation
Hospital Provincial de Castellón
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
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 Gomez, Doctor
Organizational Affiliation
Hospital Universitario La Fe
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
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
First Name & Middle Initial & Last Name & Degree
Miguel A. Muñoz, Doctor
Organizational Affiliation
Instituto Valenciano de Oncología
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan L. Martí, Doctor
Organizational Affiliation
Hospital Universitario de Alicante
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Catot, Doctor
Organizational Affiliation
Hospital Althaia, Xarxa Asistencial de Manresa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen de los Lirios
City
Alcoy
State/Province
Alicante
ZIP/Postal Code
03804
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
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 Althaia, Xarxa Asistencial de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siliva Catot, Doctor
Phone
0034938742112
Ext
3319
Email
scatot@althaia.cat
First Name & Middle Initial & Last Name & Degree
Silvia Catot, 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 Marco, Doctor
Phone
0034962659405
Email
vginermaco@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vicente Giner, Doctor
Facility Name
Hospital Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan L. Martí, Doctor
Phone
0034965938912
Email
juanluismarti@hotmail.com
First Name & Middle Initial & Last Name & Degree
Juan L. Martí, 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 Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Gómez, Doctor
Phone
0034961973138
Email
gcodina@ono.com
First Name & Middle Initial & Last Name & Degree
José Gómez, Doctor
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel A. Muñoz, Doctor
Phone
0034961114013
Email
eclinicos@fivo.org
First Name & Middle Initial & Last Name & Degree
Miguel A. Muñoz, 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
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
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