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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
Sponsor:
Information provided by (Responsible Party):
Spanish Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT01088906
First received: March 15, 2010
Last updated: January 30, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non Small Cell Lung
Drug: Pemetrexed/Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Pemetrexed Disodium Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous Cell Lung Cancer: a Phase IIA Pharmacogenomic Trial

Resource links provided by NLM:


Further study details as provided by Spanish Lung Cancer Group:

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: 90
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pemetrexed/Cisplatin
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. ANC or AGC greater than 1500 per uL
    2. Platelets greater than 100,000 per uL
    3. Total bilirubin less than 1.5mg/dL
    4. Creatinine clearance greater than or equal to 45 ml/min.
    5. 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.
  Contacts and Locations
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

Contacts
Contact: Nuria Pérez nperez@gecp.org

Locations
Spain
H. Clínica Benidorm Active, not recruiting
Benidorm, Alicante, Spain, 03501
H. General de Elche Active, not recruiting
Elche, Alicante, Spain, 03202
H. Germans Trias i Pujol Active, not recruiting
Badalona, Barcelona, Spain, 088916
H. Insular de Gran Canarias Recruiting
Las Palmas de Gran Canarias, Gran Canarias, Spain, 35016
Contact: Delvys Rodríguez, MD       delvysra@yahoo.com   
Principal Investigator: Delvys Rodríguez, MD         
H. Universitario de Canarias Recruiting
La Laguna, Tenerife, Spain, 38320
Contact: Juana Oramas, MD       joramas@huc.canarias.org   
Principal Investigator: Juana Oramas, MD         
Hospital 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
MD Anderson Active, not recruiting
Madrid, Spain, 28033
H. Morales Messeguer Active, not recruiting
Murcia, Spain, 30008
Sponsors and Collaborators
Spanish Lung Cancer Group
Investigators
Study Chair: José Miguel Sánchez Torres, MD Spanish Lung Cancer Group
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Lung Cancer Group
ClinicalTrials.gov Identifier: NCT01088906     History of Changes
Other Study ID Numbers: GECP09-01Phalcis, 2009-011327-31
Study First Received: March 15, 2010
Last Updated: January 30, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Lung Cancer Group:
Phalcis
BRCA1
RAP80
TS
First line
Non-squamous

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014