Overview

This trial is active, not recruiting.

Condition small cell lung cancer
Treatments cisplatin, etoposide
Phase phase 3
Sponsor National Cancer Institute, Naples
Start date September 2007
End date January 2016
Trial size 160 participants
Trial identifier NCT00526396, 2006-003995-36, STAD-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
standard fixed doses
cisplatin
80 mg/m2 on day 1 for 6 cycles
etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
(Experimental)
toxicity adjusted dosing
cisplatin
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
etoposide
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

Primary Outcomes

Measure
objective response
time frame: after 3 and 6 cycles of chemotherapy

Secondary Outcomes

Measure
toxicity
time frame: during and after each treatment cycle

Eligibility Criteria

Male or female participants up to 70 years old.

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

Additional Information

Official title Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
Principal investigator Cesare Gridelli, M.D.
Description The standard treatment for advanced small cell lung cancer (SCLC) is combination chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this combination have been based on calculating a patient's body surface area. This method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. Recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. This study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.