Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01167725
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Given IV
  • cetuximab — BIOLOGICAL
    Given IV
  • FOLFIRI regimen — DRUG
    Given IV
  • FOLFOX regimen — DRUG
    Given IV
  • capecitabine — DRUG
    Given IV
  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • mitomycin C — DRUG
    Given intraperitoneally
  • oxaliplatin — DRUG
    Given IV
  • therapeutic conventional surgery — PROCEDURE
    Patients undergo cytoreductive surgery

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C. PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer

Key Dates

Start date
Aug 31, 2010
Status verified
Dec 2024
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I
    Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
  • Experimental: Arm II
    Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS)

Locations (2)

FacilityCityStateZIPSite coordinators
St. Agnes Hospital Cancer CenterBaltimoreMaryland21229-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

Find similar trials in Baltimore, MD

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
St. Agnes Hospital Cancer Center· Baltimore, MDWake Forest University Comprehensive Cancer Center· Winston-Salem, NC

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