Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by National Cancer Center, Korea.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00453323
First received: March 27, 2007
Last updated: July 9, 2010
Last verified: July 2010

March 27, 2007
July 9, 2010
June 2006
December 2009   (final data collection date for primary outcome measure)
To evaluate the response rate [ Time Frame: the ratio between the number of responders and number of patients assessable for tumor response ] [ Designated as safety issue: No ]
To evaluate the response rate
Complete list of historical versions of study NCT00453323 on ClinicalTrials.gov Archive Site
  • To access the toxicity [ Time Frame: the first day of the treatment to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • To estimate the time to progression and overall survival [ Time Frame: the first day of treatment to the date that disease progression is reported ] [ Designated as safety issue: No ]
  • To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy. [ Time Frame: before the first treatment ] [ Designated as safety issue: No ]
  • To estimate the overall survival [ Time Frame: the first day of the treatment to death date ] [ Designated as safety issue: No ]
  • To access the toxicity
  • To estimate the time to progression and overall survival
  • To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.
Not Provided
Not Provided
 
Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer
A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: Paclitaxel
    paclitaxel 80mg/m2 iv on day 1 and 8, every 3 weeks
  • Drug: Capecitabine
    capecitabine 900mg/m2 bid po on day 1~14, 1 weeks rest, until disease progression
Experimental: study arm
Interventions:
  • Drug: Paclitaxel
  • Drug: Capecitabine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
33
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00453323
NCCCTS-05-156
No
Heung Tae Kim, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Heung Tae Kim, M.D. National Cancer Center, Korea
National Cancer Center, Korea
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP