Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin with Concurrent Thoracic Radiotherapy, in Patients with Unresectable Locally-Advanced Stage III, Non-Squamous, Non-Small Cell Lung Cancer - ND

• Conditions: on small cell lung cancer; MedDRA version: 9.1Level: LLTClassification code 10029520; MedDRA version: 9.1Level: LLTClassification code 10029521

• Registration Number: EUCTR2009-011739-11-IT
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-31
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Histologic or cytologic diagnosis of unresectable nonsquamous Stage IIIA or Stage IIIB (without malignant pleural/pericardial effusions) NSCLC. Squamous cell and/or mixed small cell, non-small cell histology is not permitted. See Protocol Attachment S128.2, American Joint Committee on Cancer Staging Criteria for Lung Cancer; Greene et al. 2002. [2] Have an ECOG PS of 0 or 1. See Protocol Attachment S128.3 for details. [3] Previous radiation therapy is allowed, but should have been limited and must not have included thoracic radiation, whole pelvis radiation, or radiation to >25% of the patients bone marrow (Cristy and Eckerman 1987). Patients must have recovered from the toxic effects of radiation treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. [4] Have at least 1 unidimensionally measurable lesion meeting RECIST guidelines, version 1.0 (at least 10 mm in longest diameter by spiral CT scan, or at least 20 mm by standard techniques) (see Protocol Attachment S128.4; Therasse et al. 2000). Positron emission tomography (PET) scans and ultrasounds may not be used. [5] Estimated life expectancy of at least 12 weeks. [6] Patient compliance and geographic proximity that allow adequate follow-up. [7] Adequate organ function, including the following: Adequate bone marrow reserve: leukocytes 3.0  109/L, absolute neutrophil count (ANC) 1.5  109/L, platelets 100  109/L, and hemoglobin 9 g/dL. Hepatic: bilirubin 1.5 times the upper limit of normal ( ULN) and alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) 1.5  ULN. Patients with liver transaminases between 1 and 1.5  ULN must have no indication of liver metastases on contrast-enhanced CT scan. Renal: calculated creatinine clearance (CrCl) 45 mL/min based on the standard Cockroft and Gault formula (see Protocol Attachment S128.5) and serum creatinine 1.5  ULN. Pulmonary: forced expiratory volume in 1 second (FEV1) >50% of predicted normal volume and the carbon monoxide diffusing capacity (DLCO) >40% of predicted normal value. [8] Patients must sign an ICD. [9] Patients must be at least 18 years of age. [10] Patients must have completed a 3-D plan, and the attending physician must have reviewed and approved the dose volume histograms with a total lung V20 35%. [11] For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period. [12] Have not received prior systemic anticancer therapy for NSCLC. No prior adjuvant chemotherapy is allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria: [13] Have received treatment within the last 30 days of enrollment with a drug that has not received regulatory approval for any indication at the time of study entry. [14] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15] Have a serious concomitant systemic disorder (e.g., active infection, including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patients ability to adhere to the protocol. [16] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Protocol Attachment S128.6). [17] Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low-grade (Gleason score 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [18] Are receiving concurrent administration of any other antitumor therapy. [19] Have had weight loss 10% over the previous 3 months before study entry. [20] Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose 1.3 grams per day, for at least 2 days before (5 days for long-acting agents [for example, piroxicam]), the day of, and for at least 2 days after administration of pemetrexed. [21] Are unable or unwilling to take folic acid or vitamin B12 supplementation. [22] Are unable or unwilling to take corticosteroids. [23] Have received a recent yellow fever vaccination (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination. [24] Have known hypersensitivity to pemetrexed, cisplatin, or any of the excipients in these medicinal products. [25] Have evidence of clinical hearing loss. [26] Have clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified