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Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Hospital Arnau de Vilanova

Study Description
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Brief Summary:
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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.
Study Start Date : October 2007
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate = sum of complete and partial tumour responses divided by the number of included patients [ Time Frame: 2 & 4 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: time from study entry to death from any cause ]
  2. Toxicity [ Time Frame: biweekly ]
  3. Duration of response [ Time Frame: time from first response (CR or PR) to tumor progression ]
  4. Time to progression [ Time Frame: time from study entry to observed tumor progression or death due to progression disease ]
  5. Measurement of quality of life [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905983


Locations
Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 3804
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 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 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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Vicente Alberola Candel, ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA
ClinicalTrials.gov Identifier: NCT00905983     History of Changes
Other Study ID Numbers: CPNM-ANC-07
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by Hospital Arnau de Vilanova:
Carcinoma, Non-Small-Cell
Elderly patients
Docetaxel
Gemcitabine

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