Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

NCT00209638 | Completed Phase 1

• 1 other identifier: HGCSG0002
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase I/II study of this combination in patients with inoperable or with postoperative gastric cancer

Conditions

Gastric Cancer

Keywords

Irinotecan,; S-1,; Phase I/II,; gastric cancer

Outcome Measures

Primary Outcomes (1)

• objective tumor response

Secondary Outcomes (1)

• Response duration, time to progression, overall survival, and safety will also be assessed.

Interventions

irinotecan DRUG

S-1 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:

• ・ Eligibility criteria
• Histological diagnosis of gastric adenocarcinoma.
• Measurable or assessable lesions.
• Age: 18 \~ 75 years.
• Performance Status (ECOG): 0 \~ 2.
• No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
• No history of treatment with CPT-11 or S-1.
• No history of radiotherapy to the abdomen.
• Oral intake of S-1 is possible.
• Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
• Predicted survival for \>3 months.
• Able to give written informed consent

You may not qualify if:

• Severe pleural effusion or ascites.
• Metastasis to the central nervous system (CNS).
• Active gastrointestinal bleeding.
• Active infection.
• Diarrhea (watery stools).
• Uncontrolled ischemic heart disease.
• Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
• Active multiple cancer.
• Severe mental disorder.
• Pregnancy, possible pregnancy, or breast-feeding.
• Flucytosine treatment
• Gilbert's syndrome.
• Judged to be ineligible for this protocol by the attending physician.

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2000
• Study Completion: April 1, 2003
• Last Updated: April 21, 2006

Record last verified: 2006-04