Irinotecan Versus Only Best Supportive Care for Gastric Cancer

Neoplasm Metastasis Clinical Trial

Official title:

Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144378
• Other study ID #: irinotecan vs. bsc
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: April 17, 2007
• Start date: October 2002

Study information

• Verified date: April 2007
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms
• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Drug:
• Irinotecan

Locations

Country	Name	City	State
Germany	Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median survival
Secondary	quality of life, response rates, time to tumor progression, toxicity

External Links

•   Link