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Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin (P-HDFL-DI)

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Docetaxel-Irinotecan

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Combination, Chemotherapy, Inoperable Gastric Cancer

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed gastric adenocarcinoma Measurable or evaluable disease No previous C/T Age 16 ~ 75 years Karnofsky Performance Status of 60% 4 weeks after R/T Adjuvant C/T: the last dosing of C/T 6 months before enrollment WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl Exclusion Criteria: CNS metastasis Patients receive concomitant anti-cancer C/T or R/T Patients who are pregnant and with an expected life expectancy less than 3 months Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

Sites / Locations

Department of Oncology, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A, 2, III

Arm Description

Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Objective response rates (CR, PR)

Full Information

NCT ID

NCT00166881

First Posted

September 12, 2005

Last Updated

July 4, 2013

Sponsor

National Taiwan University Hospital

Collaborators

Far Eastern Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00166881

Brief Title

Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

Acronym

P-HDFL-DI

Official Title

Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

June 2000 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

Collaborators

Far Eastern Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

Detailed Description

To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

6. Conditions and Keywords

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

Gastric Cancer

Keywords

Combination, Chemotherapy, Inoperable Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A, 2, III

Arm Type

Experimental

Arm Description

Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL

Intervention Type

Drug

Intervention Name(s)

Docetaxel-Irinotecan

Other Intervention Name(s)

Docetaxel (taxotere), Irinotecan (campto, CPT-11)

Intervention Description

Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Primary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

Five years

Secondary Outcome Measure Information:

Title

Objective response rates (CR, PR)

Time Frame

Confirmed objective response after 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann-Lii Cheng, M.D.,Ph.D.

Organizational Affiliation

Department of Oncology, National Taiwan University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oncology, National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

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