Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly 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: NCT00905983
Recruitment Status : Unknown
Verified May 2009 by Hospital Arnau de Vilanova.
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
Information provided by:
Hospital Arnau de Vilanova

May 19, 2009
May 21, 2009
May 21, 2009
October 2007
September 2009   (Final data collection date for primary outcome measure)
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients [ Time Frame: 2 & 4 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.
Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2011
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced NSCLC.
  • Stage III with pleural effusion and stage IV.
  • Patients are 70 years old.
  • Patients with 1 > ECOG PS =1.
  • 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; Leukocyte count >= 4000x10(6)/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.
  • 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 to study drugs.
  • 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.
Sexes Eligible for Study: All
70 Years and older   (Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hospital Arnau de Vilanova
Not Provided
Study Director: Oscar Juan, Doctor Hospital Arnau de Vilanova de Valencia
Principal Investigator: Alfredo Sánchez, 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 Gómez, 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: Silvia Catot, Doctor Hospital Althaia, Xarxa Asistencial de Manresa
Hospital Arnau de Vilanova
May 2009

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