Back to resultsAlimta and Gemcitabine in Non-Small Cell Lung Cancer (ANGEL)
Primary Purpose
Non-Small Cell Lung Cancer, Stage IIIB or IV
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring gemcitabine, pemetrexed, non-small cell lung cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
- No previous adjuvant or palliative chemotherapy
- No previous radiotherapy
- Presence of at least one unidimensionally measurable lesion (Appendix 2)
- ECOG performance status of 0 or 1 (Appendix 3)
- Charlson score ≤ 2 (Appendix 4)
- Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level < two times the upper limit of normal, AST and/or ALT < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
- Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
- No major surgery or pleurodesis within 14 days prior to enrollment.
- Life expectancy of at least 12 weeks.
- No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
- Written informed consent
Exclusion Criteria:
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- Patients with clinically significant effusions.
- Any other malignancies within 5 years that could affect therapy evaluation
Sites / Locations
- National Tumor Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks
Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks
Outcomes
Primary Outcome Measures
Response rate of patients treated with the gemcitabine plus Alimta regimen
Secondary Outcome Measures
Safety of patients treated with gemcitabine plus Alimta regimen
Quality of life of patients treated with gemcitabine plus Alimta regimen
Full Information
NCT ID
NCT00434135
First Posted
February 9, 2007
Last Updated
February 4, 2009
Sponsor
Southern Italy Cooperative Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00434135
Brief Title
Alimta and Gemcitabine in Non-Small Cell Lung Cancer
Acronym
ANGEL
Official Title
A Phase II Randomized Trial Assessing the Combination of Gemcitabine and Pemetrexed in the First Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Southern Italy Cooperative Oncology Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG regimen) in terms of toxicity and QoL
Detailed Description
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 & 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500 mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Stage IIIB or IV
Keywords
gemcitabine, pemetrexed, non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks
Arm Title
B
Arm Type
Active Comparator
Arm Description
Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
Intervention Description
gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8
Primary Outcome Measure Information:
Title
Response rate of patients treated with the gemcitabine plus Alimta regimen
Time Frame
after 3 cycles
Secondary Outcome Measure Information:
Title
Safety of patients treated with gemcitabine plus Alimta regimen
Time Frame
at the end of treatment
Title
Quality of life of patients treated with gemcitabine plus Alimta regimen
Time Frame
after 3 cyces
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
No previous adjuvant or palliative chemotherapy
No previous radiotherapy
Presence of at least one unidimensionally measurable lesion (Appendix 2)
ECOG performance status of 0 or 1 (Appendix 3)
Charlson score ≤ 2 (Appendix 4)
Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level < two times the upper limit of normal, AST and/or ALT < three times the upper limit of normal, prothrombin time < 1.5 times control), and creatinine clearance ≥ 60 ml/min.
Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
No major surgery or pleurodesis within 14 days prior to enrollment.
Life expectancy of at least 12 weeks.
No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
Written informed consent
Exclusion Criteria:
Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
Patients with clinically significant effusions.
Any other malignancies within 5 years that could affect therapy evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Comella, MD
Organizational Affiliation
National Tumor Institute, Naples, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Tumor Institute
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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Alimta and Gemcitabine in Non-Small Cell Lung Cancer
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