Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC (Phalcis)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Spanish Lung Cancer Group.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Spanish Lung Cancer Group
First received: March 15, 2010
Last updated: January 30, 2013
Last verified: December 2011
This is a study of pemetrexed disodium plus cisplatin as first-line therapy in patients with advanced non-squamous cell lung cancer. This is a phase IIA pharmacogenomic trial.
Carcinoma, Non Small Cell Lung
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Study of Pemetrexed Disodium Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous Cell Lung Cancer: a Phase IIA Pharmacogenomic Trial
Primary Outcome Measures:
- Objective response rate [ Time Frame: Time to progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Time until death ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day.
Other Name: The Tradename of pemetrexed is Alimta
This is a non-randomized, phase IIA pharmacogenomic, open label, uncontrolled, efficacy study in patients with advanced non-squamous cell lung cancer as a first line therapy.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with squamous cell NSCLC.
- Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Concurrent administration of any other anti-tumor therapy.
- Inability to comply with protocol or study procedures.
- Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Documented symptomatic or untreated central nervous system (CNS) metastases (except if adequately treated and stable for at least 2 weeks).
- Major surgery within 2 weeks of study or other serious concomitant systemic disorders that, in the opinion or the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
- Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia or cardiac failure not controlled by medications.
- Have peripheral neuropathy of CTCAE Grade 1 or higher
- Contraindications to corticosteroids.
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- Unwillingness to stop taking herbal supplements while on study.
- Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry and throughout study enrollment as the distribution of pemetrexed in this fluid space is not fully understood.
- Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
- Have prior known allergic/hypersensitivity reaction to any of the components of study treatment
- Inability to discontinue administration of aspirin at a dose greater than 1300 mg/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days for long-acting agents such as piroxicam).
- Female patients that is pregnant or breast-feeding.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088906
|H. Clínica Benidorm
|Benidorm, Alicante, Spain, 03501 |
|H. General de Elche
|Elche, Alicante, Spain, 03202 |
|H. Germans Trias i Pujol
|Badalona, Barcelona, Spain, 088916 |
|H. Insular de Gran Canarias
|Las Palmas de Gran Canarias, Gran Canarias, Spain, 35016 |
|Contact: Delvys Rodríguez, MD firstname.lastname@example.org |
|Principal Investigator: Delvys Rodríguez, MD |
|H. Universitario de Canarias
|La Laguna, Tenerife, Spain, 38320 |
|Contact: Juana Oramas, MD email@example.com |
|Principal Investigator: Juana Oramas, MD |
|Madrid, Spain, 28033 |
|Hospital 12 de Octubre
|Madrid, Spain, 28041 |
|H. Morales Messeguer
|Murcia, Spain, 30008 |
Spanish Lung Cancer Group
||José Miguel Sánchez Torres, MD
||Spanish Lung Cancer Group
No publications provided
||Spanish Lung Cancer Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 15, 2010
||January 30, 2013
||Spain: Spanish Agency of Medicines
Keywords provided by Spanish Lung Cancer Group:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists