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

NCT01088906 | Terminated Phase 2 Results DMC

• 2 other identifiers: GECP09-01Phalcis2009-011327-31
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Carcinoma, Non Small Cell Lung

Keywords

Phalcis; BRCA1; RAP80; TS; First line; Non-squamous

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The percentage of patients who have experienced a tumor response since the start of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  From start of treatment to end of follow up, up to 24 months

Secondary Outcomes (8)

• Overall Survival

  From the date of enrollment until end of follow up, up to 24 months.

• Time to Progression

  From the date of enrollment until end of follow up, up to 24 months.

• Time to Progression of Patients According the Results of Biomarker BRCA1

  From the date of enrollment until end of follow up, up to 24 months.

• Time to Progression of Patients According the Results of Biomarker RAP80

  From the date of enrollment until end of follow up, up to 24 months.

• Time to Progression of Patients According the Results of Biomarker TS

  From the date of enrollment until end of follow up, up to 24 months.

Study Arms (1)

1 ARM

EXPERIMENTAL

pemetrexed 500 mg/m2 IV + cisplatin 75 mg/m2 every 21 days

Drug: Pemetrexed/Cisplatin

Interventions

Pemetrexed/Cisplatin DRUG

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

Also known as: The Tradename of pemetrexed is Alimta

1 ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Study Sites (8)

H. Clínica Benidorm

Benidorm, Alicante, 03501, Spain

Location

H. General de Elche

Elche, Alicante, 03202, Spain

Location

H. Germans Trias i Pujol

Badalona, Barcelona, 088916, Spain

Location

Hospital Insular de Gran Canarias

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

H. Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

MD Anderson

Madrid, 28033, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

H. Morales Messeguer

Murcia, 30008, Spain

Location

Related Links

• Spanish Lung Cancer Group website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

26 February 2014: This study had a premature discontinuation due to the low recruitment rate of the study, not for safety reasons of the participants.

Results Point of Contact

• Title: Eva Pereira
• Organization: Fundación GECP

epereira@gecp.org

+34 934302006

Study Officials

• José Miguel Sánchez Torres, MD

  Spanish Lung Cancer Group

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 17, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)