Irinotecan Versus Only Best Supportive Care for Gastric Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Camptothecin; Irinotecan

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