Alimta and Gemcitabine in Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434135
• Other study ID #: SICOG trial 0506
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2007
• Last updated: February 4, 2009
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Southern Italy Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• Stage IIIB or IV

Intervention

Drug:
• gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
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

Locations

Country	Name	City	State
Italy	National Tumor Institute	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Southern Italy Cooperative Oncology Group

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of patients treated with the gemcitabine plus Alimta regimen		after 3 cycles	Yes
Secondary	Safety of patients treated with gemcitabine plus Alimta regimen		at the end of treatment	Yes
Secondary	Quality of life of patients treated with gemcitabine plus Alimta regimen		after 3 cyces	Yes