Overview

This trial is active, not recruiting.

Condition esophageal cancer
Treatments paclitaxel, capecitabine
Phase phase 2
Sponsor National Cancer Center, Korea
Start date June 2006
End date December 2009
Trial size 33 participants
Trial identifier NCT00453323, NCCCTS-05-156

Summary

Capecitabine is an orally administered fluoropyrimidine that is converted by 5-FU by thymidine phosphorylase (TP), preferentially in tumor tissues and has demonstrated activity as single agent in patients with gastrointestinal cancer. Up-regulation of TP after taxane treatment in vitro suggested that there may be synergistic effects in combined treatment with taxane and capecitabine. The combination of taxane and capecitabine was reported to be highly active against non-small cell lung cancer, breast cancer, and stomach cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
paclitaxel
paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
capecitabine
capecitabine 900mg/m2 bid po on day 1~14, 1 weeks rest, until disease progression

Primary Outcomes

Measure
To evaluate the response rate
time frame: the ratio between the number of responders and number of patients assessable for tumor response

Secondary Outcomes

Measure
To access the toxicity
time frame: the first day of the treatment to 30 days after the last dose of study drug
To estimate the time to progression and overall survival
time frame: the first day of treatment to the date that disease progression is reported
To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.
time frame: before the first treatment
To estimate the overall survival
time frame: the first day of the treatment to death date

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer
Principal investigator Heung Tae Kim, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by National Cancer Center, Korea.