Small Cell Lung Cancer
Conditions
Keywords
chemotherapy, toxicity adjusted dose
Brief 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.
Detailed 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.
Interventions
DRUGcisplatin
80 mg/m2 on day 1 for 6 cycles
DRUGetoposide
100 mg/m2 on days 1,2,3 for 6 cycles
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response | after 3 and 6 cycles of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | during and after each treatment cycle |
Countries
Italy
Outcome results
None listed