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
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
Germany | Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology, | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | median survival | |||
Secondary | quality of life, response rates, time to tumor progression, toxicity |
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