STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

This study is currently recruiting participants.
Verified January 2014 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00526396
First received: September 6, 2007
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: cisplatin
Drug: etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • objective response [ Time Frame: after 3 and 6 cycles of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: during and after each treatment cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
standard fixed doses
Drug: cisplatin
80 mg/m2 on day 1 for 6 cycles
Drug: etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
Experimental: B
toxicity adjusted dosing
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526396

Contacts
Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Alessandro Morabito, M.D. +39 081 5903383 alessandro.morabito@usc-intnapoli.net

Locations
Italy
Azienda Sanitaria S. Giuseppe Moscati Recruiting
Monteforte Irpino, AV, Italy
Azienda Ospedaliera G. Rummo Recruiting
Benevento, BN, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico Recruiting
Palermo, PA, Italy, 90146
Istituto Oncologico Veneto Recruiting
Padova, PD, Italy
Ospedale E. Morelli Recruiting
Sondalo, SO, Italy, 23039
Ospedale San Lazzaro Recruiting
Alba, Italy
Ospedale Mater Domini Recruiting
Catanzara, Italy
Ospedale L. Sacco Polo Universitario Recruiting
Milano, Italy
Ospedale Cotugno Recruiting
Napoli, Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Ospedale Guglielmo da Saliceto Recruiting
Piacenza, Italy
Ospedale Maggiore Recruiting
Trieste, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Cesare Gridelli, M.D. S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Principal Investigator: Massimo Di Maio, M.D. Giannettasio Hospital, Department of Oncology and Hematology
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Principal Investigator: Ciro Gallo, M.D., Ph.D Second University of Naples, Italy; Chair of Medical Statistics
  More Information

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00526396     History of Changes
Other Study ID Numbers: STAD-1, 2006-003995-36
Study First Received: September 6, 2007
Last Updated: January 2, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
chemotherapy
toxicity adjusted dose

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014