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Irinotecan Versus Only Best Supportive Care for Gastric Cancer

This study has been completed.
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 2, 2005
Last updated: April 17, 2007
Last verified: April 2007

The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.

Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.

Condition Intervention Phase
Stomach Neoplasm
Neoplasm Metastasis
Drug: Irinotecan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • median survival

Secondary Outcome Measures:
  • quality of life, response rates, time to tumor progression, toxicity

Estimated Enrollment: 44
Study Start Date: October 2002
Detailed Description:

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
  • 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
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Please refer to this study by its identifier: NCT00144378

Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: P Reichardt MD PhD Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin
Principal Investigator: PC Thuss-Patience MD PhD Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00144378     History of Changes
Other Study ID Numbers: irinotecan vs. bsc
Study First Received: September 2, 2005
Last Updated: April 17, 2007

Keywords provided by Charite University, Berlin, Germany:
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 24, 2017