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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer

2014-08-27 03:58:52 | BioPortfolio

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.

Description

OBJECTIVES:

- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.

OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.

- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.

- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.

- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.

Patients are followed every 3 months for 2 years, then every 6 months.

PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

recombinant interferon alfa, fluorouracil, leucovorin calcium, levamisole hydrochloride

Location

George Papanicolaou General Hospital
Thessaloniki
Greece
57010

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:52-0400

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Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer

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Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer

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PubMed Articles [2863 Associated PubMed Articles listed on BioPortfolio]

Control of sheep gastrointestinal nematodes using the combination of Duddingtonia flagrans and Levamisole Hydrochloride 5.

The objective was to evaluate the action of D. flagrans pellets in association with Levamisole Hydrochloride 5% for controlling sheep gastrointestinal nematodes in the northeastern Brazil. Three group...

Cocaine/levamisole-associated autoimmune syndrome: a disease of neutrophil-mediated autoimmunity.

Levamisole was previously used for its immunomodulatory properties to treat rheumatoid arthritis and some cancers. However, because of serious side-effects, it was taken off the market in the United S...

Hepatic Arterial Infusion of Oxaliplatin plus Fluorouracil/Leucovorin versus Sorafenib for Advanced Hepatocellular Carcinoma.

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Changes in in vivo confocal microscopic findings of ocular surface squamous neoplasia during treatment with topical interferon alfa-2b.

To evaluate in vivo confocal microscopy (IVCM) findings of ocular surface squamous neoplasia (OSSN) during treatment with topical interferon alfa-2b (IFN alfa-2b).

Safety and efficacy of REP 2139 and pegylated interferon alfa-2a for treatment-naive patients with chronic hepatitis B virus and hepatitis D virus co-infection (REP 301 and REP 301-LTF): a non-randomised, open-label, phase 2 trial.

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Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

The active metabolite of FOLIC ACID. Leucovorin is used principally as its calcium salt as an antidote to folic acid antagonists which block the conversion of folic acid to folinic acid.

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

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