STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cisplatin; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

• Cytologic or histologic diagnosis of small cell lung cancer

• Extensive disease according to VALG classification

• One or more target lesions.

• Performance status (ECOG) 0 or 1

• Age <70 years.

• Patients with asymptomatic cerebral metastases are eligible

• Patients who have completed treatment with radiation therapy at least 4 weeks prior to enrollment are eligible

• Written informed consent

Exclusion Criteria:

• Previous chemotherapy

• Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)

• Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl

• Creatinine > 1.5 x the upper normal limits

• GOT and/or GPT > 2.5 and/or Bilirubin > 1.5 times the upper normal limits in absence of hepatic metastases

• GOT and/or GPT > 5 and/or Bilirubin > 3 times the upper normal limits in presence of hepatic metastases

• Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study

• Hypersensitivity to darbepoetin alpha, to r-HuEPO or their components

• Uncontrolled hypertension.

• Inability to provide informed consent.

• Inability to comply with follow-up