STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00526396
First received: September 6, 2007
Last updated: February 27, 2013
Last verified: February 2013
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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: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (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: | February 27, 2013 |
| 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 May 16, 2013