A Phase II Study of Irinotecan, Oxaliplatin, Plus TS-1 in Untreated Metastatic Gastric Cancer

NCT00512681 | Completed Phase 2

• 1 other identifier: NCCCTS-07-264
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasms; Secondary; Combination chemotherapy; S-1; irinotecan; oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Maximal overall response rate

  During chemotherapy

Secondary Outcomes (1)

• Progression-free survival,Overall survival,Toxicity assessment,&genetic polymorphism and association with chemical outcomes

  during study period

Interventions

Irinotecan, Oxaliplatin, TS-1 DRUG

* S-1 40 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning) * Irinotecan 150 mg/m2 mixed in d5w 500 ml iv over 90-min on days 1 * Oxaliplatin 85 mg/m2 mixed in d5w 250 ml iv over 2-h on days 1

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
• Age ≥18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
• No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed.
• Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL
• Patients should sign a written informed consent before study entry

You may not qualify if:

• Prior history of peripheral neuropathy
• Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
• Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
• Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
• Psychiatric disorder that would preclude compliance
• Pregnant, nursing women or patients with reproductive potential without contraception
• Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

Irinotecan; Oxaliplatin; titanium silicide

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; Coordination Complexes; Organic Chemicals

Study Officials

• Sook Ryun Park, M.D.

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

KR (1)