Alimta and Gemcitabine in Non-Small Cell Lung Cancer

NCT00434135 | Completed Phase 2

• 1 other identifier: SICOG trial 0506
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Small Cell Lung Cancer; Stage IIIB or IV

Keywords

gemcitabine; pemetrexed; non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response rate of patients treated with the gemcitabine plus Alimta regimen

  after 3 cycles

Secondary Outcomes (2)

• Safety of patients treated with gemcitabine plus Alimta regimen

  at the end of treatment

• Quality of life of patients treated with gemcitabine plus Alimta regimen

  after 3 cyces

Study Arms (2)

A

EXPERIMENTAL

Gemcitabine 1,250 mg/sqm days 1 and 8 + Alimta 500 mg/sqm day 8, every 3 weeks

Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine

B

ACTIVE COMPARATOR

Paclitaxel 120 mg/sqm days 1 and 8 + Gemcitabine 1,000 mg/sqm days 1 and 8, every 3 weeks

Drug: gemcitabine plus pemetrexed, paclitaxel plus gemcitabine

Interventions

gemcitabine plus pemetrexed, paclitaxel plus gemcitabine DRUG

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

A; B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Italy Cooperative Oncology Group: lead

Study Sites (1)

National Tumor Institute

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Pemetrexed; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Pasquale Comella, MD

  National Tumor Institute, Naples, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 12, 2007
• Study Start: May 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2008
• Last Updated: February 5, 2009

Record last verified: 2009-02

Locations

IT (1)