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Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Paclitaxel

Capecitabine

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Phase II, Metastatic esophageal cancer, Recurrent esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the response rate

Secondary Outcome Measures

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.

To estimate the overall survival

Full Information

NCT ID

NCT00453323

First Posted

March 27, 2007

Last Updated

July 9, 2010

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00453323

Brief Title

Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

To evaluate the response rate

Time Frame

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

Secondary Outcome Measure Information:

Title

To access the toxicity

Time Frame

the first day of the treatment to 30 days after the last dose of study drug

Title

To estimate the time to progression and overall survival

Time Frame

the first day of treatment to the date that disease progression is reported

Title

To evaluate the expression of TP in tumor tissues as a predictive marker for paclitaxel-capecitabine chemotherapy.

Time Frame

before the first treatment

Title

To estimate the overall survival

Time Frame

the first day of the treatment to death date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

21888637

Citation

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.

Results Reference

derived

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Paclitaxel and Capecitabine in Patients With Metastatic/Recurrence Esophageal Cancer

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