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

NCT ID: NCT00606021

Last Updated: 2011-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-12-31

Brief 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).

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Pemetrexed + Best Supportive Care

Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (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.

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care

Intervention Type: DRUG

Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

B: Best Supportive Care

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Group Type: ACTIVE_COMPARATOR

Best Supportive Care

Intervention Type: DRUG

Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Interventions

pemetrexed

500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles

Intervention Type: DRUG

Best Supportive Care

Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Intervention Type: DRUG

Other Intervention Names

Alimta; LY231514

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Asyut, , 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, , 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.

Beirut, , 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.

Riyadh, , Saudi Arabia

Countries

Egypt; Lebanon; Saudi Arabia

References

Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.

Reference Type: DERIVED

PMID: 23006447 (View on PubMed)

Other Identifiers

H3E-EZ-S114

Identifier Type: OTHER

Identifier Source: secondary_id

11839

Identifier Type: -

Identifier Source: org_study_id