- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905983
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients
May 19, 2009 updated by: Hospital Arnau de Vilanova
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alicante, Spain, 03550
- Hospital San Juan de Alicante
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Valencia, Spain, 46009
- Instituto Valenciano de Oncologia
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Valencia, Spain, 46009
- Hospital Universitario La Fé
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Valencia, Spain, 46015
- Hospital Arnau de Vilanova
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Valencia, Spain, 46017
- Hospital Universitario Dr. Peset
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Alicante
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Alcoy, Alicante, Spain, 3804
- Hospital Virgen de los Lirios
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Benidorm, Alicante, Spain, 03501
- Hospital Clínica de Benidorm
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Elda, Alicante, Spain, 03600
- Hospital General de Elda
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Barcelona
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Manresa, Barcelona, Spain, 08243
- Hospital Althaia, Xarxa Asistencial de Manresa
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Castellón
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Castellón de la Plana, Castellón, Spain, 12002
- Hospital Provincial de Castellón
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Valencia
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Sagunto, Valencia, Spain, 46520
- Hospital de Sagunto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time Frame: 2 & 4 months
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2 & 4 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of response
Time Frame: time from first response (CR or PR) to tumor progression
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time from first response (CR or PR) to tumor progression
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Time to progression
Time Frame: time from study entry to observed tumor progression or death due to progression disease
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time from study entry to observed tumor progression or death due to progression disease
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Measurement of quality of life
Time Frame: 28 days
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28 days
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Overall survival
Time Frame: time from study entry to death from any cause
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time from study entry to death from any cause
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Toxicity
Time Frame: biweekly
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biweekly
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Anticipated)
September 1, 2009
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
May 19, 2009
First Submitted That Met QC Criteria
May 19, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Estimate)
May 21, 2009
Last Update Submitted That Met QC Criteria
May 19, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gemcitabine
- Docetaxel
Other Study ID Numbers
- CPNM-ANC-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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