CClinicalTrials.gg
Status unknownNCT00453323Updated Jul 12, 2010

Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

A Phase 2 interventional study of Paclitaxel and Capecitabine in Esophageal Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal Cancer
  • Phase II
  • Metastatic esophageal cancer
  • Recurrent esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 33 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    study arm

    Drug: Paclitaxel · Drug: Capecitabine

Interventions

  • DrugPaclitaxel

    paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks

  • DrugCapecitabine

    capecitabine 900mg/m2 bid po on day 1\~14, 1 weeks rest, until disease progression

06

What researchers measure

Primary outcomes

  1. To evaluate the response rate

    Time frame: the ratio between the number of responders and number of patients assessable for tumor response

Secondary outcomes

  1. To access the toxicity

    Time frame: 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

    Time frame: 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.

    Time frame: before the first treatment

  4. To estimate the overall survival

    Time frame: the first day of the treatment to death date

07

Study locations

1 site
  • National Cancer Center, Korea
    Goyang-si, Gyeonggi-do 411-769, Korea, Republic of
08

References and documents

Publications

  • Yun T, Han JY, Lee JS, Choi HL, Kim HY, Nam BH, Kim HT. Phase II study of weekly paclitaxel and capecitabine in patients with metastatic or recurrent esophageal squamous cell carcinoma. BMC Cancer. 2011 Sep 2;11:385. doi: 10.1186/1471-2407-11-385. PubMed 21888637 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00453323
Lead sponsor
National Cancer Center, Korea
First posted
Mar 28, 2007
Start date
Jun 2006
Primary completion
Dec 2009
Completion
Dec 2010 (estimated)
Last update
Jul 12, 2010

Study contacts

Heung Tae Kim, M.D.
principal investigator · National Cancer Center, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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