Study of Gamma Interfereon in Metastatic Colorectal Carcinoma

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Accelerated Community Oncology Research Network
Study ID
NCT00786643
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5-Fluorouracil — DRUG
    5-FU bolus was administered at 400mg/m\^2 on day 1 and day 2 of each cycle. 5-FU at 600 mg/m\^2 infusion was administered over 22 hours on day 1 and day 2 of each cycle.
  • Leucovorin (LV) — DRUG
    Leucovorin 200mg/m\^2 was administered over 2 hours on day 1 and day 2 of each cycle.
  • Gamma-Interferon-1b (IFN-γ) — DRUG
    Gamma-Interferon 150 mcg/m\^2 was administered by subcutaneous injection on day 1 of each cycle immediately before treatment with 5-FU and LV, and on day 3 of each cycle immediately after treatment with 5-FU and LV.
  • Bevacizumab — DRUG
    Bevacizumab 5mg/kg was only added to the treatment regimen of patients in stratum 1 who demonstrated stable disease on imaging repeated prior to the 5th cycle of treatment. Bavacizumab was administered on day 4 of each cycle.

Study Details

The purpose of this study is to evalute the response and toxicity of metastatic colorectal cancer patients to the regimen of gamma interferon added to bolus and infusional 5-fluorouracil and leucovorin (GFL) with or without bevacizumab.

Key Dates

First listed
Nov 6, 2008
Start date
Feb 28, 2006
Status verified
Feb 2012
Primary completion
Mar 31, 2010
Completion
Mar 31, 2010

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1
    Patients in stratum 1 have not received prior chemotherapy in the metastatic setting.
  • Experimental: Stratum 2
    Patients in stratum 2 have received 1-2 prior chemotherapy regimens in the metastatic setting.

Primary Outcome Measure

Best Response (BR) [ Time Frame: After every 4 cycles of treatment (approximately every 56 days for up to about 280 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
The West ClinicMemphisTennessee38120-

Find similar trials in Memphis, TN

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
The West Clinic· Memphis, TN

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