Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

Part of paid clinical trials in Los Angeles, California.

Sponsor
NYU Langone Health
Study ID
NCT00848783
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
  • Cisplatin — DRUG
  • Surgery — PROCEDURE
  • Floxuridine — DRUG
  • Capecitabine — DRUG

Study Details

This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.

Key Dates

Start date
May 31, 2008
Status verified
Dec 2017
Primary completion
Aug 31, 2011
Completion
Sep 30, 2012

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A-with IP Floxuridine
    1. Induction treatment: Cisplatin 25 mg/m\^2 and Irinotecan 75 mg/m\^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once. 2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease. 3. Randomization 4. Surgery. 5. Postoperative IP treatment: Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m\^2, IP; 2 weeks without treatment; repeat the course once 6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m\^2/day x14 every 3 weeks/course, Oral
  • Experimental: B-Without IP Floxuridine
    Same as Arm A except no postoperative IP treatment.

Primary Outcome Measure

Number of Patients With One-year Recurrence-free Survival [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Norris Cancer CenterLos AngelesCalifornia90033-
Bellevue HospitalNew YorkNew York10016-
NYU Cancer CenterNew YorkNew York10016-

Find similar trials in Los Angeles, CA

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Norris Cancer Center· Los Angeles, CABellevue Hospital· New York, NYNYU Cancer Center· New York, NY

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