Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer
Λέξεις-κλειδιά
Αφηρημένη
Περιγραφή
Paclitaxel-80 mg/m2/IV D1 & D8 q 3 weeks Capecitabine-900 mg/m2/PO twice daily Days 1-14 q 3 weeks
Patients receive treatment every 3 weeks till disease progression.
Ημερομηνίες
| Τελευταία επαλήθευση: | 06/30/2010 |
| Πρώτα υποβλήθηκε: | 03/26/2007 |
| Υποβλήθηκε εκτιμώμενη εγγραφή: | 03/26/2007 |
| Δημοσιεύτηκε για πρώτη φορά: | 03/27/2007 |
| Υποβλήθηκε τελευταία ενημέρωση: | 07/08/2010 |
| Δημοσιεύτηκε η τελευταία ενημέρωση: | 07/11/2010 |
| Ημερομηνία έναρξης της πραγματικής μελέτης: | 05/31/2006 |
| Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: | 11/30/2009 |
| Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: | 11/30/2010 |
Κατάσταση ή ασθένεια
Παρέμβαση / θεραπεία
Drug: study arm
Drug: study arm
Φάση
Ομάδες βραχιόνων
| Μπράτσο | Παρέμβαση / θεραπεία |
|---|---|
| Experimental: study arm | Drug: study arm paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks |
Κριτήρια καταλληλότητας
| Επιλέξιμες ηλικίες για μελέτη | 18 Years Προς την 18 Years |
| Φύλα επιλέξιμα για μελέτη | All |
| Δέχεται υγιείς εθελοντές | Ναί |
| Κριτήρια | Inclusion Criteria: 1. Histologically or cytologically confirmed esophageal cancer with histology of squamous carcinoma or adenocarcinoma 2. Clinically diagnosed metastatic or recurrent esophageal cancer according to Sixth Edition of the AJCC Cancer Staging Manual (Appendix V) 3. At least 18 years old 4. Disease status must be that of measurable disease defined as RECIST:Lesions that can be accurately measured in at least one dimension > 10 mm with chest x-ray, spiral CT scan or physical examination 5. ECOG performance status 0-2 6. No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed 7. Adequate major organ function including the following:Hematologic function: WBC ≥ 3,500/mm3 or absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3Hepatic function: bilirubin ≤ 1.5 x UNL , AST/ALT levels ≤ 2.5 x UNLRenal function: serum creatinine ≤ 1.5mg/dL 8. Patients should sign an informed consent 9. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study enrollment. Exclusion Criteria: 1. MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia 2. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy 3. Pregnant or nursing women 4. Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer 5. Psychiatric disorder that would preclude compliance. 6. Major surgery other than biopsy within the past two weeks |
Αποτέλεσμα
Πρωτεύοντα αποτελέσματα
1. To evaluate the response rate [the ratio between the number of responders and number of patients assessable for tumor response]
Δευτερεύοντα αποτελέσματα
1. To access the toxicity [the first day of the treatment to 30 days after the last dose of study drug]
2. To estimate the time to progression and overall survival [the first day of treatment to the date that disease progression is reported]
3. To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy. [before the first treatment]
4. To estimate the overall survival [the first day of the treatment to death date]
