STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed70 and underOtherSTAD-1
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, Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00526396
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.