Clinical trial NCT00144378: Irinotecan Versus Only Best Supportive Care for Gastric Cancer
Official title: Randomized Phase III Study With Irinotecan+Best Supportive Care Versus Only Best Supportive Care as Second Line Therapy for Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stomach Neoplasm
Neoplasm Metastasis
Keywords: gastric cancer
metastatic
irinotecan
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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

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

Primary outcomes:
measure: median survival
Secondary outcomes:
measure: quality of life, response rates, time to tumor progression, toxicity
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité,Universitätsmedizin Berlin, Campus Virchow Klinikum, Dep. orf Hematology and Oncology,
Study officials:
affiliation: Charité, University,Campus Virchow Klinikum, Dep. of Hematology and Oncology,Berlin
name: P Reichardt MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité, University,Campus Virchow Klinikum,Dep. of Hematology and Oncology
name: PC Thuss-Patience MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.