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

July 4, 2013 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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
  2. 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
  3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
  4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Department of Oncology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed gastric adenocarcinoma
  2. Measurable or evaluable disease
  3. No previous C/T
  4. Age 16 ~ 75 years
  5. Karnofsky Performance Status of 60%
  6. 4 weeks after R/T
  7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment
  8. WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl

Exclusion Criteria:

  1. CNS metastasis
  2. Patients receive concomitant anti-cancer C/T or R/T
  3. Patients who are pregnant and with an expected life expectancy less than 3 months
  4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, 2, III
Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
Drug: Docetaxel-Irinotecan
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
Other Names:
  • Docetaxel (taxotere)
  • Irinotecan (campto, CPT-11)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rates (CR, PR)
Time Frame: Confirmed objective response after 4 weeks
Confirmed objective response after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Far Eastern Memorial Hospital

Investigators

  • Study Chair: Ann-Lii Cheng, M.D.,Ph.D., Department of Oncology, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 4, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57M9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Docetaxel-Irinotecan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe