Study of Pemetrexed Plus Cisplatin as First-line Therapy in Patients With Advanced Non-squamous NSCLC

Carcinoma, Non Small Cell Lung Clinical Trial

— Phalcis  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01088906
• Other study ID #: GECP09-01Phalcis
• Secondary ID: 2009-011327-31
• Status: Terminated
• Phase: Phase 2
• First received: March 15, 2010
• Last updated: July 3, 2015
• Start date: January 2010
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Pemetrexed/Cisplatin
Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day.

Locations

Country	Name	City	State
Spain	H. Germans Trias i Pujol	Badalona	Barcelona
Spain	H. Clínica Benidorm	Benidorm	Alicante
Spain	H. General de Elche	Elche	Alicante
Spain	H. Universitario de Canarias	La Laguna	Tenerife
Spain	H. Insular de Gran Canarias	Las Palmas de Gran Canarias	Gran Canarias
Spain	Hospital 12 de Octubre	Madrid
Spain	MD Anderson	Madrid
Spain	H. Morales Messeguer	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		Time to progression	No
Secondary	Overall survival		Time until death	Yes

External Links

•   Spanish Lung Cancer Group website