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Completed

NCT Number: NCT00313872

Phase III Trial of DP 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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

DP

Drug

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

FOLFIRI

Drug

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

Primary outcomes

  1. Second progress-free survival

    Time frame: 2years

Secondary outcomes

  1. Toxicity, overall survival

    Time frame: 2years

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Apr 12, 2006
Registry last updated
Jan 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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