Trial | NCT00526396  Report issue

Title

STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    160
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.
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.
Study Started
Sep 30
2007
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Mar 24
2023

Drug cisplatin

80 mg/m2 on day 1 for 6 cycles

Drug etoposide

100 mg/m2 on days 1,2,3 for 6 cycles

Drug cisplatin

cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle

Drug etoposide

etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

A Active Comparator

standard fixed doses

B Experimental

toxicity adjusted dosing

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
No Results Posted