Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
NCT ID: NCT00906061
Last Updated: 2009-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
76 participants
INTERVENTIONAL
2007-10-31
2011-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Gemcitabine and Docetaxel
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
Interventions
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Gemcitabine and Docetaxel
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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Hospital Arnau de Vilanova
OTHER
Responsible Party
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ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
Principal Investigators
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Oscar Juan, Doctor
Role: STUDY_DIRECTOR
Hospital Arnau de Vilanova de Valencia
Alfredo Sanchez, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Provincial de Castellón
José Muñoz, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Universitario Dr. Peset
Sonia Maciá, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Elda
Vicente Giner, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital de Sagunto
José Gomez, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Gaspar Esquerdo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínica de Benidorm
Antonio López, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital San Juan de Alicante
Francisco Aparisi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Virgen de los Lirios
Miguel A. Muñoz, Doctor
Role: PRINCIPAL_INVESTIGATOR
Instituto Valenciano de Oncología
Juan L. Martí, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Alicante
Silvia Catot, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Althaia, Xarxa Asistencial de Manresa
Locations
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Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital Universitario de Alicante
Alicante, Alicante, Spain
Hospital San Juan de Alicante
Alicante, Alicante, Spain
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain
Hospital General de Elda
Elda, Alicante, Spain
Hospital Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain
Hospital Provincial de Castellón
Castellon, Castellón, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Valencia, Spain
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CPNM-PS2-07
Identifier Type: -
Identifier Source: org_study_id
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