Clinical trial NCT00606021: A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-02-01
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression Free Survival During Maintenance Phase
timeFrame: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Secondary outcomes:
measure: Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
timeFrame: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
measure: Overall Survival During Maintenance Phase
timeFrame: Randomization to PD or date of death from any cause up to 31.3 months
measure: Overall Survival During Overall Period (IP + MP)
timeFrame: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
measure: Number of Participants With Adverse Events (AEs) During Overall Period
timeFrame: First dose of study drug during IP through overall study completion (up to 34.3) months
measure: Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
timeFrame: Randomization to measured PD up to 31.4 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: 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.
city: Cairo
country: Egypt
facility: 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.
city: Mounofia
country: Egypt
facility: 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.
city: Beirut
country: Lebanon
facility: 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.
city: Riyadh
country: Saudi Arabia
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.