Clinical trial NCT00526396: STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: chemotherapy
toxicity adjusted dose
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 160
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: objective response
timeFrame: after 3 and 6 cycles of chemotherapy
Secondary outcomes:
measure: toxicity
timeFrame: during and after each treatment cycle
Other outcomes:
Locations:
city: Monteforte Irpino
country: Italy
facility: Azienda Sanitaria S. Giuseppe Moscati
state: AV
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
state: PA
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Sondalo
country: Italy
facility: Ospedale E. Morelli
state: SO
city: Alba
country: Italy
facility: Ospedale San Lazzaro
city: Catanzara
country: Italy
facility: Ospedale Mater Domini
city: Milano
country: Italy
facility: Ospedale L. Sacco Polo Universitario
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Ospedale Cotugno
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Trieste
country: Italy
facility: Ospedale Maggiore
Study officials:
affiliation: S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
name: Cesare Gridelli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Giannettasio Hospital, Department of Oncology and Hematology
name: Massimo Di Maio, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair of Medical Statistics
name: Ciro Gallo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morabito A, Daniele G, Costanzo R, Favaretto AG, Filipazzi V, Rossi A, Gebbia V, Castiglione F, Cavanna L, Maiello E, Sandomenico C, Bonanno L, Piazza E, Maione P, Piccirillo MC, Di Maio M, Rocco G, Gallo C, Perrone F, Gridelli C. A multicenter, randomized, phase 3 trial comparing fixed dose versus toxicity-adjusted dose of cisplatin + etoposide in extensive small-cell lung cancer (SCLC) patients: The Small-cell-lung cancer Toxicity Adjusted Dosing (STAD-1) trial. Lung Cancer. 2017 Jun;108:15-21. doi: 10.1016/j.lungcan.2017.02.016. Epub 2017 Feb 27.