Irinotecan Versus Only Best Supportive Care for Gastric Cancer

NCT ID: NCT00144378

Last Updated: 2007-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31

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.

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

Conditions

Stomach Neoplasm; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Interventions

Irinotecan

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Principal Investigators

P Reichardt MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

PC Thuss-Patience MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,

Berlin, , Germany

Countries

Germany

References

Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.

Reference Type: DERIVED

PMID: 21742485 (View on PubMed)

Other Identifiers

irinotecan vs. bsc

Identifier Type: -

Identifier Source: org_study_id