A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606021
• Other study ID #: 11839
• Secondary ID: H3E-EZ-S114
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: November 21, 2011
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and PopulationSaudi Arabia: Research Advisory CouncilLebanon: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. You must be at least 18 years old

2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)

3. You must have had no prior systemic anticancer therapy for lung cancer

4. You must live close enough to the study doctor to be able to visit regularly for follow up

5. You must have signed informed consent form indicating your willingness to take part in this study

6. Your laboratory and medical history and tests must meet study requirements

Exclusion criteria:

1. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment

3. Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)

4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence

5. Brain metastasis

6. Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry

7. Significant weight loss (greater than 10%), over the previous 6 weeks before study entry

8. Concurrent administration of any other antitumor therapy

9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)

10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation

11. Pregnancy or breast-feeding

12. You are allergic to pemetrexed

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

Intervention

Drug:
• pemetrexed
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
• Best Supportive Care
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Locations

Country	Name	City	State
Egypt	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Assiut
Egypt	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cairo
Egypt	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mounofia
Lebanon	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Beirut
Saudi Arabia	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Egypt,  Lebanon,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival During Maintenance Phase	Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is =20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.	Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months	No
Secondary	Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])	Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is =20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.	First dose of study drug during IP to PD or date of death from any cause up to 33.6 months	No
Secondary	Overall Survival During Maintenance Phase	Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.	Randomization to PD or date of death from any cause up to 31.3 months	No
Secondary	Overall Survival During Overall Period (IP + MP)	Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.	First dose of study drug during IP to PD or date of death from any cause up to 34.1 months	No
Secondary	Number of Participants With Adverse Events (AEs) During Overall Period	The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.	First dose of study drug during IP through overall study completion (up to 34.3) months	Yes
Secondary	Tumor Response Rate and Disease Control Rate After Induction Phase (IP)	Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is=20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.	Randomization to measured PD up to 31.4 months	No

External Links

•   Lilly Clinical Trial Registry