EUCTR2007-000913-13-GBActive, not recruitingNot Applicable
Phase 2 Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 55
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •[1]Histologic and/or cytologic diagnosis of Limited Stage of Small Cell Lung Cancer, without cytological proven malignant pleural effusion and confined to 1 hemithorax.
- •[2]Performance status of 0 to 1 on the ECOG performance status schedule
- •[3]At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques).
- •[4]Adequate organ function, including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets =100 x 109/L, and haemoglobin = 9 g/dL.
- •Hepatic: bilirubin =1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransaminase (ALT) = 3.0 x ULN.
- •Renal: calculated creatinine clearance (CrCl)= 45 mL/min based on the standard Cockcroft and Gault formula.
- •[5]Adequate pulmonary function as defined as a forced expiratory volume in 1 sec (FEV1) >30% predicted normal value and diffusion capacity (DLCO) >40% predicted normal value.
- •[6]Signed informed consent document from patient.
- •[7]Males or females at least 18 years of age.
- •[8]For 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 the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrolment 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.
- •[9]Patient compliance and geographic proximity that allows for adequate follow-up.
- •[10]Estimated life expectancy of at least 12 weeks.
- •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 Number of subjects for this age range
Exclusion Criteria
- •[11]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[12]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.
- •[13]Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
- •[14]Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
- •[15]Have had a prior malignancy other than Small Cell Lung Cancer, carcinoma in situ of the cervix, or nonmelanoma 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.
- •[16]Prior chemotherapy for this cancer and/or prior TRT
- •[17]Pregnancy/breast-feeding.
- •[18]Significant weight loss (that is = 10%) over the previous 6 weeks before study entry.
- •[19]Concurrent administration of any other anti-tumour therapy.
- •[20]Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose = 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- •[21]Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •[22]Inability to take corticosteroids.
- •[23]Completion or withdrawal from this study or any other study investigating pemetrexed, carboplatin, and/or Thoracic Radiotherapy.
- •[24]Inability or unwillingness to comply with the protocol or study procedures.
Investigators
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