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Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Hospital Arnau de Vilanova
ClinicalTrials.gov Identifier:
NCT00906061
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Gemcitabine and Docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital Arnau de Vilanova:

Primary Outcome Measures:
  • Overall response rate = sum of complete and partial tumour responses divided by the number of included patients [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Time from study entry to death from any cause ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Biweekly ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ] [ Designated as safety issue: No ]
  • Measurement of quality of life [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: October 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Drug: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906061

Locations
Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
Hospital Clínica de Benidorm
Benidorm, Alicante, Spain, 03501
Hospital General de Elda
Elda, Alicante, Spain, 03600
Hospital Althaia, Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain, 08243
Hospital Provincial de Castellón
Castellón de la Plana, Castellón, Spain, 12002
Hospital de Sagunto
Sagunto, Valencia, Spain, 46520
Hospital Universitario de Alicante
Alicante, Spain, 03010
Hospital San Juan de Alicante
Alicante, Spain, 03550
Hospital Universitario La Fe
Valencia, Spain, 46009
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Hospital Arnau de Vilanova
Investigators
Study Director: Oscar Juan, Doctor Hospital Arnau de Vilanova de Valencia
Principal Investigator: Alfredo Sanchez, Doctor Hospital Provincial de Castellón
Principal Investigator: José Muñoz, Doctor H. Universitario Dr. Peset
Principal Investigator: Sonia Maciá, Doctor Hospital General de Elda
Principal Investigator: Vicente Giner, Doctor Hospital de Sagunto
Principal Investigator: José Gomez, Doctor Hospital Universitario La Fe
Principal Investigator: Gaspar Esquerdo, Doctor Hospital Clínica de Benidorm
Principal Investigator: Antonio López, Doctor Hospital San Juan de Alicante
Principal Investigator: Francisco Aparisi, Doctor Hospital Virgen de los Lirios
Principal Investigator: Miguel A. Muñoz, Doctor Instituto Valenciano de Oncología
Principal Investigator: Juan L. Martí, Doctor Hospital Universitario de Alicante
Principal Investigator: Silvia Catot, Doctor Hospital Althaia, Xarxa Asistencial de Manresa
  More Information

Responsible Party: Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
ClinicalTrials.gov Identifier: NCT00906061     History of Changes
Other Study ID Numbers: CPNM-PS2-07 
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Arnau de Vilanova:
Carcinoma, Small Cell
Lung Neoplasms
Docetaxel
Gemcitabine
ECOG 2

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on December 08, 2016