A randomised phase II study of pemetrexed compared to pemetrexed-carboplatin in pretreated patients with advanced non-small cell lung cancer

Completed

• Conditions: on Small Cell Lung Cancer (NSCLC); Cancer; Lung cancer

• Registration Number: ISRCTN38269072
• Lead Sponsor: VU University Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-11
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

1. Histologically or cytologically confirmed NSCLC locally advanced and metastatic disease stage IIIB and IV, with evidence of disease progression after cytotoxic treatment which should have included a platinum agent
2. At least three months from prior chemotherapy with complete recovery from first line chemotherapy side effects to less than grade two
3. At least one unidimensionally measurable leasion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria
4. Eastern Cooperative Oncology Group (ECOG) performance status zero to two
5. Aged greater than 18 years
6. Adequate organ function, including:
a. adequate bone marrow reserve: Absolute Neutrophil Count (ANC) greater than 1.5 x 10^9/L, platelets greater than 100 x 10^9/L
b. hepatic: bilirubin less than 1.5 x Upper Limit of Normal (ULN), Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) less than 3.0 x ULN. AP, ALT, and AST less than 5 x ULN is acceptable if the liver has tumour involvement
c. renal: calculated creatinine clearance greater than 45 ml/min based on the Cockroft and Gault formula
7. Signed informed consent
8. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within seven days prior to study enrolment
9. Estimated life expectancy greater than 12 weeks
10. Patient compliance and geographical proximity that allow adequate follow up

Exclusion Criteria

1. Pregnant or lactating women
2. Patients who are poor medical risks because of non-malignant disease as well as those with active uncontrolled infection
3. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrolment
4. Concomitant treatment with any other experimental drug under investigation
5. Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a five-day period (eight day period for long-acting agents such as piroxicam)
6. Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone

Study & Design

• Study Type: Interventional
• Study Design: Not specified