A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer
NCT ID: NCT00789373
Last Updated: 2018-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
939 participants
INTERVENTIONAL
2008-11-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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pemetrexed + cisplatin followed by pemetrexed
pemetrexed plus cisplatin followed by pemetrexed plus best supportive care
Pemetrexed
Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
Cisplatin
Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles
Pemetrexed
Maintenance therapy: 500 mg/m\^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Best Supportive Care
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
pemetrexed + cisplatin followed by placebo
pemetrexed plus cisplatin followed by placebo plus best supportive care
Pemetrexed
Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
Cisplatin
Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles
Placebo
Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
Best Supportive Care
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
Interventions
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Pemetrexed
Induction therapy: 500 mg/m\^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
Cisplatin
Induction therapy: Cisplatin: 75 mg/m\^2, IV, on Day 1 of each 21-day cycle for 4 cycles
Placebo
Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
Pemetrexed
Maintenance therapy: 500 mg/m\^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Best Supportive Care
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
* You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
* You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.
* Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.
* You must be 18 years of age or older.
* Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).
* You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
* You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase.
Exclusion Criteria
* You cannot have received other investigational drugs within the last 30 days of entering the trial.
* You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
* You cannot have other serious on-going illnesses including active infections.
* You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
* You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.
* You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.
* You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).
* You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
* You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.
* You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).
* You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
* You cannot be pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Adelaide, South Australia, Australia
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Frankston, Victoria, Australia
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Wendouree, Victoria, Australia
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Aalst, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Gilly, , Belgium
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Liège, , Belgium
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Sint-Niklaas, , Belgium
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Espoo, , Finland
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Avignon, , France
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Dijon, , France
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Le Mans, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Vandœuvre-lès-Nancy, , France
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Frankfurt, , Germany
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Gerlingen, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Ulm, , Germany
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Athens, , Greece
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Chania, , Greece
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Neo Faliro, , Greece
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Pátrai, , Greece
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Bangalore, , India
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Bhopal, , India
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Madurai, , India
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Mumbai, , India
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Patna, , India
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Avellino, , Italy
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Aviano, , Italy
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Genova, , Italy
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Lido di Camaiore, , Italy
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Monza, , Italy
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Pisa, , Italy
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Reggio Emilia, , Italy
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Rome, , Italy
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Udine, , Italy
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Ede, , Netherlands
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Groningen, , Netherlands
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Harderwijk, , Netherlands
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Heerlen, , Netherlands
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Poznan, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Vila Franca de Xira, , Portugal
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Oradea, , Romania
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Manresa, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Bornova, , Turkey (Türkiye)
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Sihhiye, , Turkey (Türkiye)
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Zeytinburnu, , Turkey (Türkiye)
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Aberdeen, Scotland, United Kingdom
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Guildford, Surrey, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Newcastle, , United Kingdom
Countries
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References
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Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.
Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.
Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.
Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H3E-EW-S124
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2009/091/000113
Identifier Type: REGISTRY
Identifier Source: secondary_id
12560
Identifier Type: -
Identifier Source: org_study_id