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

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ClinicalTrials.gov Identifier: NCT00313872
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Metastases Drug: DP Drug: FOLFIRI Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Study Start Date : May 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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 <WNL, mix MgSO4 1 amp) 20% Mannitol 70 mL IV full dripping, 30 mins before cisplatin D2-D3 Dexamethasone 8 mg PO bid, D4-D5 Dexamethasone 4 mg PO bid every 3 weeks




Primary Outcome Measures :
  1. Second progress-free survival [ Time Frame: 2years ]

Secondary Outcome Measures :
  1. Toxicity, overall survival [ Time Frame: 2years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313872


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Won Ki Kang, MD Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00313872     History of Changes
Other Study ID Numbers: SMC IRB 2005-03-044
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Samsung Medical Center:
gastric cancer
chemotherapy
irinotecan
docetaxel

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Irinotecan
Docetaxel
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators