Alimta and Gemcitabine in Non-Small Cell Lung Cancer
Information source: Southern Italy Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer; Stage IIIB or IV
Intervention: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Southern Italy Cooperative Oncology Group Official(s) and/or principal investigator(s): Pasquale Comella, MD, Principal Investigator, Affiliation: National Tumor Institute, Naples, Italy
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate of patients treated with the gemcitabine plus Alimta regimen
Secondary outcome: Safety of patients treated with gemcitabine plus Alimta regimenQuality of life of patients treated with gemcitabine plus Alimta regimen
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with histologically or cytologically confirmed locally advanced (stage
IIIB) or metastatic (stage IV) NSCLC
2. No previous adjuvant or palliative chemotherapy
3. No previous radiotherapy
4. Presence of at least one unidimensionally measurable lesion (Appendix 2)
5. ECOG performance status of 0 or 1 (Appendix 3)
6. Charlson score ≤ 2 (Appendix 4)
7. 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.
8. 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.
9. No major surgery or pleurodesis within 14 days prior to enrollment.
10. Life expectancy of at least 12 weeks.
11. 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.
12. Written informed consent
Exclusion Criteria:
1. Any unstable systemic disease (including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, serious cardiac arrhythmia requiring
medication, hepatic, renal or metabolic disease).
2. Patients with clinically significant effusions.
3. Any other malignancies within 5 years that could affect therapy evaluation
Locations and Contacts
National Tumor Institute, Naples 80131, Italy
Additional Information
Starting date: May 2006
Last updated: February 4, 2009
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