Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase II Study of Weekly Paclitaxel and Capecitabine in Patients With Metastatic or Recurrent Esophageal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00453323
• Other study ID #: NCCCTS-05-156
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: July 9, 2010
• Start date: June 2006
• Est. completion date: December 2010

Study information

• Verified date: July 2010
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response rate		the ratio between the number of responders and number of patients assessable for tumor response	No
Secondary	To access the toxicity		the first day of the treatment to 30 days after the last dose of study drug	Yes
Secondary	To estimate the time to progression and overall survival		the first day of treatment to the date that disease progression is reported	No
Secondary	To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.		before the first treatment	No
Secondary	To estimate the overall survival		the first day of the treatment to death date	No