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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00453323 |
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Date of registration:
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27/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer
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Scientific title:
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A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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33 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00453323 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Heung Tae Kim, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Cancer Center, Korea |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Esophageal Cancer
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Intervention(s)
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Drug: Capecitabine
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Drug: Paclitaxel
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Primary Outcome(s)
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To evaluate the response rate
[Time Frame: the ratio between the number of responders and number of patients assessable for tumor response]
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Secondary Outcome(s)
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To estimate the overall survival
[Time Frame: the first day of the treatment to death date]
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To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.
[Time Frame: before the first treatment]
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To access the toxicity
[Time Frame: the first day of the treatment to 30 days after the last dose of study drug]
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To estimate the time to progression and overall survival
[Time Frame: the first day of treatment to the date that disease progression is reported]
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Secondary ID(s)
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NCCCTS-05-156
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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