A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy

NCT00506207 | Unknown Phase 1

• 1 other identifier: NCCCTS-06-166
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.

Conditions

Colorectal Neoplasm; Gastric Neoplasm; Secondary

Keywords

Gastrointestinal neoplasms; Combination chemotherapy; S-1; Irinotecan; Oxaliplatin

Outcome Measures

Primary Outcomes (2)

• Toxicity measured by NCICTC v.3

  During treatment

• Blood level of irinotecan and S-1 and their metabolites

  At 1st cycle

Secondary Outcomes (1)

• Maximal response rate, progression-free survival, survival

Interventions

S-1, Irinotecan, Oxaliplatin DRUG

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 unresectable or metastatic colorectal or gastric carcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions
• Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed
• Adequate major organ functions
• Patients should sign a written informed consent before study entry

You may not qualify if:

• Prior history of peripheral neuropathy
• Inadequate cardiovascular
• Serious concurrent infection or nonmalignant illness
• 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, phenytoin, or warfarin et al.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Neoplasm Metastasis; Gastrointestinal Neoplasms

Interventions

S 1 (combination); Irinotecan; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal 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

• Kyung Hae Jung, M.D.Ph.D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: September 1, 2006
• Study Completion: December 1, 2009
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

KR (1)