Irinotecan Versus Only Best Supportive Care for Gastric Cancer

NCT00144378 | Completed Phase 3

• 1 other identifier: irinotecan vs. bsc
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasm; Neoplasm Metastasis

Keywords

gastric cancer; metastatic; irinotecan

Outcome Measures

Primary Outcomes (1)

• median survival

Secondary Outcomes (1)

• quality of life, response rates, time to tumor progression, toxicity

Interventions

Irinotecan DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 21742485 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• P Reichardt MD PhD

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

  PRINCIPAL INVESTIGATOR

• PC Thuss-Patience MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: October 1, 2002
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

DE (1)