Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

January 10, 2012 updated by: Samsung Medical Center

Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

To assess the optimal sequence of the palliative chemotherapy regimen (DP --> FOLFIRI vs FOLFIRI --> DP) in metastatic gastric cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed metastatic adenocarcinoma of the stomach
  2. Age ≥ 18
  3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  4. Life expectancy of at least 3 months
  5. Adequate renal, liver, bone marrow functions
  6. Adjuvant chemotherapy more than 12 months from the date of study entry
  7. Written informed consent

Exclusion Criteria:

  1. Active infection requiring antibiotics
  2. Pregnant, lactating women
  3. Brain metastasis
  4. Systemic illness not appropriate for chemotherapy
  5. Radiotherapy within 2 weeks before the study entry
  6. Allergy to drugs used in the trial

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FOLFIRI
Drug: FOLFIRI
FOLFIRI regimen D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
Experimental: DP

D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr, D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr

D1 Irinotecan 150 mg/m2 + D5W 500mL MIV over 90 min D1 Leucovorin 100 mg/m2 + D5W 500mL MIV over 2hrs D1-2 5-FU 1500 mg/m2 + D5W 1000 ml CIV over 24 hrs (total 2doses) D1 atropine 0.3mg SQ before irinotecan
Drug: DP
D1 Taxotere 75 mg/m2 + D5W 200 mL IV over 1 hr D1 Cisplatin 75 mg/m2 + NS 150mL MIV over 1hr Pre & Post medication Dexamethasone 8mg PO D0 Night (X1) D1 immediately upon waking in the morning, 1 hour before infusion Taxotere, Night (X3) D0 NS 1500 mL IV overnight hydration D1 DNK2 1000 mL IV over 2 hours, pre & post hydration (if Mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Second progress-free survival
Time Frame: 2years
2years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity, overall survival
Time Frame: 2years
2years

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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

May 1, 2003

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC IRB 2005-03-044

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.

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