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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00906061
Recruitment Status : Unknown
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Information provided by:
Hospital Arnau de Vilanova

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 21, 2009
Last Update Posted Date May 21, 2009
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients [ Time Frame: 2 and 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • Overall survival [ Time Frame: Time from study entry to death from any cause ]
  • Toxicity [ Time Frame: Biweekly ]
  • Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ]
  • Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ]
  • Measurement of quality of life [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Official Title  ICMJE Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Intervention: Drug: Gemcitabine and Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00906061
Other Study ID Numbers  ICMJE CPNM-PS2-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Study Sponsor  ICMJE Hospital Arnau de Vilanova
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital Arnau de Vilanova
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP