Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

NCT00453323 | Unknown Phase 2

• 1 other identifier: NCCCTS-05-156
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Phase II; Metastatic esophageal cancer; Recurrent esophageal cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the response rate

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

Secondary Outcomes (4)

• To access the toxicity

  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

  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.

  before the first treatment

• To estimate the overall survival

  the first day of the treatment to death date

Study Arms (1)

study arm

EXPERIMENTAL

Drug: Paclitaxel; Drug: Capecitabine

Interventions

Paclitaxel DRUG

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

study arm

Capecitabine DRUG

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

study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed esophageal cancer with histology of squamous carcinoma or adenocarcinoma
• Clinically diagnosed metastatic or recurrent esophageal cancer according to Sixth Edition of the AJCC Cancer Staging Manual (Appendix V)
• At least 18 years old
• 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
• ECOG performance status 0-2
• No prior radiotherapy to measurable lesion(s) but previous surgery and/or chest radiotherapy for the primary lesion is allowed
• 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
• Patients should sign an informed consent
• 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.

You may not qualify if:

• MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complication of study therapy
• Pregnant or nursing women
• Other malignancy with the past 5 years except adequately treated cutaneous basal cell carcinoma or uterine cervix in situ cancer
• Psychiatric disorder that would preclude compliance.
• Major surgery other than biopsy within the past two weeks

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21888637 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Heung Tae Kim, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: July 12, 2010

Record last verified: 2010-07

Locations

KR (1)