Irinotecan Versus Only Best Supportive Care for Gastric Cancer

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00144378
First received: September 2, 2005
Last updated: April 17, 2007
Last verified: April 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00144378     History of Changes
Other Study ID Numbers: irinotecan vs. bsc
Study First Received: September 2, 2005
Last Updated: April 17, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014