STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: etoposide
* Drug: cisplatin
* Drug: etoposide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>standard fixed doses | Drug: cisplatin<br>* 80 mg/m2 on day 1 for 6 cycles<br>Drug: etoposide<br>* 100 mg/m2 on days 1,2,3 for 6 cycles<br>|
| Experimental: B<br>toxicity adjusted dosing | Drug: cisplatin<br>* cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle<br>Drug: etoposide<br>* etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response |  | after 3 and 6 cycles of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | during and after each treatment cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, toxicity adjusted dose