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A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

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Status and phase

Completed
Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Dexamethasone
Drug: Vitamin B12
Drug: Pemetrexed
Drug: Folic Acid
Drug: Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01165021
13621
H3E-EW-JMIP (Other Identifier)

Details and patient eligibility

About

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
  • Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
  • Tumor considered potentially resectable
  • Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
  • No prior therapy for lung cancer
  • Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
  • Life expectancy of at least 6 months
  • Organs are functioning well (bone marrow reserve, liver, kidney, lung)
  • Signed Informed Consent
  • Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
  • Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
  • Be fit for surgery at the time of enrollment

Exclusion criteria

  • Receiving or have received an investigational drug or device within the last 30 days
  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Serious concomitant systemic disorder
  • Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
  • Receiving concurrent administration of any other anticancer therapy
  • Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
  • Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Pemetrexed + Cisplatin
Experimental group
Treatment:
Drug: Vitamin B12
Drug: Dexamethasone
Drug: Folic Acid
Drug: Cisplatin
Drug: Pemetrexed

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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