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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 70 and under Other STAD-1 EudraCT number 2006-003995-36, NCT00526396

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute of Naples

Cesare Gridelli

Principal Investigator

Massimo Di Maio, M.D.

Principal Investigator

Francesco Perrone

Principal Investigator

Ciro Gallo, M.D., Ph.D

Principal Investigator

Francesco Perrone, M.D., Ph.D.		Ph: +39 081 5903571
		Email: francesco.perrone@uosc.fondazionepascale.it

Alessandro Morabito, M.D.		Ph: +39 081 5903383
		Email: alessandro.morabito@uosc.fondazionepascale.it

Italy
	Alba
	Ospedale San Lazzaro
	Benevento
	Azienda Ospedaliena G. Rummo
	Campobasso
	Ospedale Cardarelli - Campobasso
	Isernia
	Ospedale F. Veneziale
	Monteforte Irpino
	S.G. Moscati Hospital
	Napoli
	Istituto Nazionale dei Tumori
	Ospedale Cotugno
	Padova
	Ospedale Busonera - Divisione Oncologia Medica
	Palermo
	Ospedale La Maddalena - Palermo
	Ospedale Oncology M. Ascoli
	Piacenza
	Ospedale Guglielmo da Saliceto
	Sondalo
	Azienda Ospedale E. Morelli
	Trieste
	Ospedale Maggiore
South Australia
	Vallo della Lucania
	Ospedale S. Luca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00526396
Information obtained from ClinicalTrials.gov on November 09, 2008