Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
N/A
70 Years
Both
Small Cell Lung Cancer
Trial Information
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
objective response
Outcome Time Frame:
after 3 and 6 cycles of chemotherapy
Safety Issue:
No
Principal Investigator
Cesare Gridelli, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Authority:
Italy: Ethics Committee
Study ID:
STAD-1
NCT ID:
NCT00526396
Start Date:
September 2007
Completion Date:
September 2014
Related Keywords:
- Small Cell Lung Cancer
- chemotherapy
- toxicity adjusted dose
- Lung Neoplasms
- Small Cell Lung Carcinoma
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