MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gemcitabine prolonged continuous infusion
cisplatin
vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring elderly, chemotherapy, quality of life, ADL, toxicity
Eligibility Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis of NSCLC
- Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
- Age > o = 70 years.
- Written informed consent.
Exclusion Criteria:
- Performance status (ECOG) ³2
- Previous chemotherapy.
- Symptomatic brain metastases requiring synchronous radiotherapy
- Previous radiotherapy (completed less than 4 weeks before enrollment)
- Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
- Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
- Serum creatinine > 1.5 times the UNL.
- GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases.
- GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases.
- Other concomitant diseases contraindicating the study treatments.
- Refusal of written informed consent.
- Follow-up impossible.
Sites / Locations
Outcomes
Primary Outcome Measures
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
Secondary Outcome Measures
patient quality of life
the prognostic significance of the ADL and IADL scales for time to progression and survival
exploratory predictive clinical variables for chemotherapy related toxicity
exploratory predictive clinical variables for response to chemotherapy
Full Information
NCT ID
NCT00401492
First Posted
November 17, 2006
Last Updated
July 12, 2012
Sponsor
National Cancer Institute, Naples
1. Study Identification
Unique Protocol Identification Number
NCT00401492
Brief Title
MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
Official Title
Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer
Detailed Description
The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 & 8 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
elderly, chemotherapy, quality of life, ADL, toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine prolonged continuous infusion
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Primary Outcome Measure Information:
Title
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Title
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
Secondary Outcome Measure Information:
Title
patient quality of life
Title
the prognostic significance of the ADL and IADL scales for time to progression and survival
Title
exploratory predictive clinical variables for chemotherapy related toxicity
Title
exploratory predictive clinical variables for response to chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic diagnosis of NSCLC
Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
Age > o = 70 years.
Written informed consent.
Exclusion Criteria:
Performance status (ECOG) ³2
Previous chemotherapy.
Symptomatic brain metastases requiring synchronous radiotherapy
Previous radiotherapy (completed less than 4 weeks before enrollment)
Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
Serum creatinine > 1.5 times the UNL.
GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases.
GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases.
Other concomitant diseases contraindicating the study treatments.
Refusal of written informed consent.
Follow-up impossible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, M.D.
Organizational Affiliation
San Giuseppe Moscati Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D.
Organizational Affiliation
National Cancer Institute, Naples Italy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17925563
Citation
Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.
Results Reference
result
PubMed Identifier
18683299
Citation
Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.
Results Reference
result
Learn more about this trial
MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
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