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

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer; Metastases

Treatments: Drug: FOLFIRI; Drug: DP

Study type: Interventional

Funder types: Other

Identifiers

NCT00313872

SMC IRB 2005-03-044

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

FOLFIRI

Experimental group

Treatment:

Drug: FOLFIRI

DP

Experimental group

Description:

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

Treatment:

Drug: DP