- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088906
Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC (Phalcis)
July 3, 2015 updated by: Spanish Lung Cancer Group
Study of Pemetrexed Disodium Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous Cell Lung Cancer: a Phase IIA Pharmacogenomic Trial
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Madrid, Spain, 28033
- MD Anderson
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Murcia, Spain, 30008
- H. Morales Messeguer
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Alicante
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Benidorm, Alicante, Spain, 03501
- H. Clínica Benidorm
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Elche, Alicante, Spain, 03202
- H. General de Elche
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Barcelona
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Badalona, Barcelona, Spain, 088916
- H. Germans Trias i Pujol
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Gran Canarias
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Las Palmas de Gran Canarias, Gran Canarias, Spain, 35016
- H. Insular de Gran Canarias
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Tenerife
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La Laguna, Tenerife, Spain, 38320
- H. Universitario de Canarias
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of non-squamous NSCLC, that is not amenable to curative treatment with surgery or radiation therapy. This population encompasses advanced stage patients with select stage IIIB (with pleural or pericardial effusion) or stage IV disease. Histologic or cytologic documentation of recurrence is required in patients who were previously completely resected and now have progressive disease.
- Tissue must be available to generate and apply the genomics predictor. If not obtained at the time of diagnosis, then subject must consent to another biopsy. If patient had prior radiation therapy, tissue biopsy for genomics analysis must be outside radiation field.
- At least one, non-radiated, measurable lesion by RECIST criteria.
- ECOG performance status of 0 or 1
- No prior chemotherapy, biologic or targeted therapy for any malignancy.
- Prior radiation therapy is permitted if ≥1 week since completion of radiation treatment. Radiation must be <25% of bone marrow reserve.
- Age greater than 18 years.
- No previous or concomitant malignancy in the past 5 years other than surgical management for carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.
- No other serious medical or psychiatric illness.
- Signed informed consent.
- Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test. Both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug.
Required laboratory data within two weeks of enrollment:
- ANC or AGC greater than 1500 per uL
- Platelets greater than 100,000 per uL
- Total bilirubin less than 1.5mg/dL
- Creatinine clearance greater than or equal to 45 ml/min.
- SGOT/SGPT less than or equal to 3x/ULN except in presence of known hepatic metastases in which it may be up to 5x ULN.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 ARM
pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days
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Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days.
A cycle is 21 day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate
Time Frame: Time to progression
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Time to progression
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Time until death
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Time until death
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: José Miguel Sánchez Torres, MD, Spanish Lung Cancer Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
March 15, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimate)
March 17, 2010
Study Record Updates
Last Update Posted (Estimate)
July 7, 2015
Last Update Submitted That Met QC Criteria
July 3, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- GECP09-01Phalcis
- 2009-011327-31 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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