Antecedentes en investigación clínica
Publicaciones internacionales de los estudios de investigación clínica realizados en el centro oncológico de rosario desde el año 1998.
Letrosol a new aromatase inhibitor: randomised trial comparing 2.5mg.daily, 0.5mg.daily and aminoglutethimide in postmenopausal women with advanced breast cancer.
Annals of Oncology 96:639-645 june 1998
ESTUDIO DE REGISTROSurvival advantage of Exemestane over Megestrol in postmenopausal women with advanced breast cancer refractory to Tamoxifen. Results of a Phase III randomised double-blind Study.
European Journal of cancer vol.35, 4 de September 1999: pp 84
ESTUDIO DE REGISTRO- Survival advantage of Exemestane over Megestrol Acetate in postmenopausal women with advanced breast cancer, refractory to Tamoxifen. Results of phase III randomized double blind Study.
J Clin Oncol , vol. 18, N° 7 ( April ), 2000: pp 1399-1411
ESTUDIO DE REGISTRO - Activity of Exemestane in metastatic Breast Cancer after failure of nonsteroidal aromatase inhibitors: A Phase II Trial.
J Clin Oncol, vol. 18, N° 11 ( june ), 2000: pp 2234-2244 - Femara (letrosole) showed significant improvement in efficacy over tamoxifen as first line treatment in postmenopausal women with advanced Breast cancer.
Breast cancer research and treatment, vol. 64, N° 1 november (I), 2000: pp27 - Phase II study of weekly intravenous Estramustin phosphate 2000 mg. In patiens with hormone-refractory prostate cancer.
Proc Am Soc Clin Oncol . 2001. Abstract #731 Zoledronic acid versus Pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III, double blind, comparative trial.
Cancer journal, 2001;7:377-387
ESTUDIO DE REGISTRO- Zoledronic acid significantly reduce skeletal related events in patients with osteolytic bone metastases from NSMCLC and other solid tumors.
IASLC Rejkjavik , Iceland , August 8-12, 2001 , Abstract #23 Zometa significantly increased the median time to first skeletal related event in patients en patients with osteolytic bone metastases from nom small cell lung cancer and other solid tumors.
Second Internacional Chicago symposium on malignancies of the chest and head & neck.
October 4-6, Chicago / USA .
Lung cancer 34 (1), 2001:pp 67- A new bisphosphonate ZOMETA decreases skeletal complications in both lytic and blastic lesions: comparison to pamidronate.
Chemoterapy foundation symposium XIX innovative cancer theraphy for tomorrow.
November 7-10, 2001 New York/ USA.
ESTUDIO DE REGISTRO A phase III randomized trial (COLON-OXALAD) of adjuvant therapy for very high risk colon cancer patiens with oxaliplatin +/- bolus 5-fluoruracil/folinic acid: a toxicity report.
Proc Am Soc Clin Oncol . 2002. Abstract #656
Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Interim results of a global phase III study.
Proc Am Soc Clin Oncol . 2002. Abstract #25
ESTUDIO DE REGISTROPhase III single-blinded study of pemetrexed + cisplatin vs. cisplatin alone in chemonaive patients with malignant pleural mesothelioma.
Plenary Session 2002 ASCO Annual Meeting.
ESTUDIO DE REGISTRORamdomized phase II trial of Irofulven (IROF) with or without prednisone in hormone-refractory prostate cancer (HRPC) patiens (PTS).
Proc Am Soc Clin Oncol . 2003. Abstract #1636. Poster presentation.Zoledronic acid is effective in preventing and delaying skeletal events in patients with bone metastases secondary to prostate and renal cancer.
Proc Am Soc Clin Oncol . 2003. Abstract # 1523. Poster presentation.Under-reporting of symptoms in patients with early breast cancer who received Tamoxifen treatment for 2-3 years.
Proc Am Soc Clin Oncol . 2003. Abstract #48 . Poster presentation.Phase III Study of Letrozole Versus Tamoxifen as First-Line Therapy of Advanced Breast Cancer in Postmenopausal Women: Analysis of Survival and Update of Efficacy From the International Letrozole Breast Cancer Group.
J Clin Oncol 2003 Jun 1: 2101-2109- Phase III Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Alone in Patients With Malignant Pleural Mesothelioma.
J Clin Oncol 2003 Jul 15: 2636-2644
ESTUDIO DE REGISTRO First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts) – A randomized phase III trial of the EORTC Breast Group.
Proc Am Soc Clin Oncol . 2004. Abstract #515Global phase III study of gemcitabine plus paclitaxel vs. paclitaxel as frontline therapy for metastatic breast cancer: first report of overall survival.
Proc Am Soc Clin Oncol . 2004. Abstract #510- Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1.
J Clin Oncol . 2004 Mar 1;22(5):777-84
Inspecciones de Autoridades Regulatorias:
Department of Health and Human Services.
Public Health Service.
Food and Drug Administration (FDA).
26 al 28 Abril 1998.
RESULTADO: Sin acción indicada. Ninguna condición o práctica objetable fueron encontradas durante la inspección.
Letrosol a new aromatase inhibitor: randomised trial comparing 2.5mg.daily, 0.5mg.daily and aminoglutethimide in postmenopausal women with advanced breast cancer.
Annals of Oncology 96:639-645 june 1998
ESTUDIO DE REGISTRO
Survival advantage of Exemestane over Megestrol in postmenopausal women with advanced breast cancer refractory to Tamoxifen. Results of a Phase III randomised double-blind Study.
European Journal of cancer vol.35, 4 de September 1999: pp 84
ESTUDIO DE REGISTRO
Survival advantage of Exemestane over Megestrol Acetate in postmenopausal women with advanced breast cancer, refractory to Tamoxifen. Results of phase III randomized double blind Study.
J Clin Oncol , vol. 18, N° 7 ( April ), 2000: pp 1399-1411
ESTUDIO DE REGISTRO
Activity of Exemestane in metastatic Breast Cancer after failure of nonsteroidal aromatase inhibitors: A Phase II Trial.
J Clin Oncol, vol. 18, N° 11 ( june ), 2000: pp 2234-2244
Femara (letrosole) showed significant improvement in efficacy over tamoxifen as first line treatment in postmenopausal women with advanced Breast cancer.
Breast cancer research and treatment, vol. 64, N° 1 november (I), 2000: pp27
Phase II study of weekly intravenous Estramustin phosphate 2000 mg. In patiens with hormone-refractory prostate cancer.
Proc Am Soc Clin Oncol . 2001. Abstract #731
Zoledronic acid versus Pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III, double blind, comparative trial.
Cancer journal, 2001;7:377-387
ESTUDIO DE REGISTRO
Zoledronic acid significantly reduce skeletal related events in patients with osteolytic bone metastases from NSMCLC and other solid tumors.
IASLC Rejkjavik , Iceland , August 8-12, 2001 , Abstract #23
Zometa significantly increased the median time to first skeletal related event in patients en patients with osteolytic bone metastases from nom small cell lung cancer and other solid tumors.
Second Internacional Chicago symposium on malignancies of the chest and head & neck.
October 4-6, Chicago / USA .
Lung cancer 34 (1), 2001:pp 67
A new bisphosphonate ZOMETA decreases skeletal complications in both lytic and blastic lesions: comparison to pamidronate.
Chemoterapy foundation symposium XIX innovative cancer theraphy for tomorrow.
November 7-10, 2001 New York/ USA.
ESTUDIO DE REGISTRO
A phase III randomized trial (COLON-OXALAD) of adjuvant therapy for very high risk colon cancer patiens with oxaliplatin +/- bolus 5-fluoruracil/folinic acid: a toxicity report.
Proc Am Soc Clin Oncol . 2002. Abstract #656
Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Interim results of a global phase III study.
Proc Am Soc Clin Oncol . 2002. Abstract #25
ESTUDIO DE REGISTRO
Phase III single-blinded study of pemetrexed + cisplatin vs. cisplatin alone in chemonaive patients with malignant pleural mesothelioma.
Plenary Session 2002 ASCO Annual Meeting.
ESTUDIO DE REGISTRO
Ramdomized phase II trial of Irofulven (IROF) with or without prednisone in hormone-refractory prostate cancer (HRPC) patiens (PTS).
Proc Am Soc Clin Oncol . 2003. Abstract #1636. Poster presentation.
Zoledronic acid is effective in preventing and delaying skeletal events in patients with bone metastases secondary to prostate and renal cancer.
Proc Am Soc Clin Oncol . 2003. Abstract # 1523. Poster presentation.
Under-reporting of symptoms in patients with early breast cancer who received Tamoxifen treatment for 2-3 years.
Proc Am Soc Clin Oncol . 2003. Abstract #48 . Poster presentation.
Phase III Study of Letrozole Versus Tamoxifen as First-Line Therapy of Advanced Breast Cancer in Postmenopausal Women: Analysis of Survival and Update of Efficacy From the International Letrozole Breast Cancer Group.
J Clin Oncol 2003 Jun 1: 2101-2109
Phase III Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Alone in Patients With Malignant Pleural Mesothelioma.
J Clin Oncol 2003 Jul 15: 2636-2644
ESTUDIO DE REGISTRO
First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts) – A randomized phase III trial of the EORTC Breast Group.
Proc Am Soc Clin Oncol . 2004. Abstract #515
Global phase III study of gemcitabine plus paclitaxel vs. paclitaxel as frontline therapy for metastatic breast cancer: first report of overall survival.
Proc Am Soc Clin Oncol . 2004. Abstract #510
Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1.
J Clin Oncol . 2004 Mar 1;22(5):777-84
Inspecciones de Autoridades Regulatorias:
Department of Health and Human Services.
Public Health Service.
Food and Drug Administration (FDA).
26 al 28 Abril 1998.
RESULTADO: Sin acción indicada. Ninguna condición o práctica objetable fueron encontradas durante la inspección.
