Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT01280643
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • fluorouracil — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • cetuximab — BIOLOGICAL
    Given IV
  • capecitabine — DRUG
    Given PO
  • mutation analysis — GENETIC
    Correlative studies
  • gene expression analysis — GENETIC
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • immunohistochemistry staining method — OTHER
    Correlative studies
  • nucleic acid sequencing — GENETIC
    Correlative studies
  • protein expression analysis — GENETIC
    Correlative studies
  • polymerase chain reaction — GENETIC
    Correlative studies
  • DNA analysis — GENETIC
    Correlative studies

Study Details

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, oxaliplatin, capecitabine, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells. PURPOSE:To evaluate the use of standard (KRAS) and experimental (thymidine phosphorylase, ERCC1 and BRAF) tumor testing can aid in selecting chemotherapy regimens

Key Dates

Start date
Mar 31, 2010
Status verified
Feb 2021
Primary completion
Jul 31, 2013
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Arm A
    Patients receive FOLFIRI (FOLolinic acid (leucovorin) Fluorouracil (5-FU) IRInotecan (irinotecan)) chemotherapy comprising fluorouracil intravenously (IV) over 46 hours continuously, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.
  • Experimental: Arm B
    Patients receive FOLFOX (FOL- Folinic acid (leucovorin) F - Fluorouracil (5-FU) OX - Oxaliplatin (Eloxatin)) chemotherapy comprising fluorouracil IV over 46 hours continuously on day 1 and leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on days 1 and 15. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.
  • Experimental: Arm C
    Patients receive FOLFIRI chemotherapy as in Arm A and bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Experimental: Arm D
    Patients receive FOLFOX chemotherapy as in Arm B and bevacizumab IV over 30-90 minutes on days 1 and 15.
  • Experimental: Arm E
    Patients receive CapeIRI (Capecitabine and Irinotecan) chemotherapy comprising capecitabine orally (PO) twice daily (BID) on days 1-14 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.
  • Experimental: Arm F
    Patients receive CapeOX (capecitabine (Xeloda) and oxaliplatin (Eloxatin)) chemotherapy comprising capecitabine PO BID on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 1 and 8.
  • Experimental: ARM G
    Patients receive CapeIRI chemotherapy as in Arm E and bevacizumab IV over 30-90 minutes on day 1.
  • Experimental: Arm H
    Patients receive CapeOX chemotherapy as in Arm F and bevacizumab IV over 30-90 minutes on day 1.
  • Experimental: Arm I
    Patients receive treatment as in Arm D.

Primary Outcome Measure

Feasibility, Defined as a Sufficient Proportion of Subjects Having Available Tissue and an Acceptable Composite Assay Success Rate Among Tested Subjects [ Time Frame: Over 21 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2497-

Find similar trials in Philadelphia, PA

By research site
Fox Chase Cancer Center· Philadelphia, PA

Related Studies