Irinotecan Versus Only Best Supportive Care for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144378
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : April 18, 2007
Information provided by:
Charite University, Berlin, Germany

Brief Summary:

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 or disease Intervention/treatment Phase
Stomach Neoplasm Neoplasm Metastasis Drug: Irinotecan Phase 3

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. median survival

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00144378     History of Changes
Other Study ID Numbers: irinotecan vs. bsc
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: April 18, 2007
Last Verified: April 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