STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

National Cancer Institute, Naples

Status and phase

Active, not recruiting

Phase 3

Conditions

Small Cell Lung Cancer

Treatments

Drug: cisplatin

Drug: etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT00526396

STAD-1

2006-003995-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

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