Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00062374
Phase
PHASE2
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • Stage II Gastric Cancer
  • Stage III Gastric Cancer
  • Stage IV Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo FDG and FLT PET/CT
  • Fludeoxyglucose F-18 — RADIATION
    Undergo FDG-PET/CT
  • Fluorothymidine F-18 — OTHER
    Undergo FLT-PET/CT
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG and FLT PET/CT
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo radical subtotal or total gastrectomy with lymph node dissection

Study Details

This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.

Key Dates

Start date
Jun 30, 2003
Status verified
Jun 2017
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (preoperative chemotherapy)
    Neoadjuvant chemotherapy: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Surgery: Within 4 weeks after completion of neoadjuvant chemotherapy, patients undergo radical subtotal or total gastrectomy with lymph node dissection.

Primary Outcome Measure

Histological Response Determined by FDG Uptake Correlates [ Time Frame: Day 15 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

Related Studies