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Irinotecan Versus Only Best Supportive Care for Gastric Cancer
This study has been completed.
Sponsored by: Charite University, Berlin, Germany
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00144378
  Purpose

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 III

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144378

Locations
Germany
Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: irinotecan vs. bsc
Study First Received: September 2, 2005
Last Updated: April 17, 2007
ClinicalTrials.gov Identifier: NCT00144378  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Irinotecan
Neoplasm Metastasis
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009