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Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer

Phase 3
18 Years
75 Years
Not Enrolling
Stomach Neoplasm, Neoplasm Metastasis

Thank you

Trial Information

Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer

Metastatic gastric cancer, progressive disease after one palliative chemotherapy

Arm A:

Irinotecan 250/350 mg/m2 q3w

1. Cycle:250mg/m2/ 30min

2. Cycle:If no toxicity>2° CTC, nor Leuko-thrombopenia>3° occured, dose is increased to
350mg/m2 Arm B. Best supportive care

Inclusion Criteria:

- Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal

- Patient with distant metastases laparoscopically proven operative incurability of an
locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy

- Patient with progressive disease under a palliative first-line chemotherapy or
progressive disease within 6 months after termination of a first-line chemotherapy,
defined as objective progression by imaging techniques according to WHO criteria

- Age 18 and 75 years

- Sufficient liver function, defined as serum-bilirubin <1,5 mg/dl (1,5 upper normal
limit), ALT und AST < 3x upper normal limit

- Sufficient renal function, defined as serum creatinine < 1,25 x upper normal limit or
creatinine clearance >60ml/min calculated according to Crockroft-Gault

- Contraction for patient with reproductive potential

- Karnofsky-Index >60%

- Measurable or evaluable tumor manifestation

Exclusion Criteria:

- Tumor progression later than 6 months after termination of first-line chemotherapy

- KI 50% or less

- Patient who have already received a second line chemotherapy for the metastatic
setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed,
biologic prior therapies are allowed)

- Prior or current second malignancy despite of basal carcinoma of the skin and
curatively treated carcinoma in situ of the cervix

- Uncontrolled infection

- CNS metastases

- Other severe medical illness

- Prior major surgery less than 2 weeks ago

- Parallel treatment with another experimental therapy

- Parallel treatment with another therapy aiming at tumor reduction

- Chronic diarrhea, subileus

- Chronic inflammatory bowel disease or intestinal obstruction

- Pretreatment with irinotecan

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Outcome Measure:

median survival

Principal Investigator

P Reichardt MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

irinotecan vs. bsc



Start Date:

October 2002

Completion Date:

Related Keywords:

  • Stomach Neoplasm
  • Neoplasm Metastasis
  • gastric cancer
  • metastatic
  • irinotecan
  • Neoplasms
  • Stomach Neoplasms
  • Neoplasm Metastasis